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Mustapha 2014
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Balloon angioplasty in tibioperoneal interventions for patients with critical limb ischemia
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Tibial arterial disease represents the final frontier in the battle against critical limb ischemia (CLI). Isolated infrapopliteal (IP) disease is mainly seen in the elderly (>80 years old), diabetic, and dialysis-dependent patients with CLI. With the development and evolution of catheter-based technology, endovascular therapy (mainly balloon angioplasty) has become the method of choice for revascularization in these patients. The most common challenges are the severely calcified lesion recalcitrant to dilation (as calcium is heterogeneously distributed in the arterial wall) and the long tibial chronic total occlusions. Percutaneous transluminal angioplasty achieves a technically successful result (<30% residual stenosis) in most cases, but it is limited by high restenosis rates. Although several devices have been used in the IP arena (including orbital and directional atherectomy, laser atherectomy, "contact" atherectomy [CROSSER, Bard], and re-entry devices), percutaneous transluminal angioplasty with plain old balloons has been the subject of most studies with several modified iterations, that is, cryoplasty, cutting balloons, focal force balloons, nitinol-"cage"-constrained balloons, tapered balloons, and most recently drug-coated balloons. In this article, we share our current approach to endovascular IP endovascular interventions. We cover the spectrum from pathophysiology, clinical indications, equipment choices, and procedural steps used in our laboratory when treating patients with CLI (which is synonymous with complex anatomy). Regarding what represents the "gold standard" for the treatment of IP disease, a definite answer is currently not available, as multiple studies looking at new generation drug-coated balloons used alone or in combination with different forms of atherectomy are currently under way. We anxiously wait for these results and in the meantime continue to design newer approaches.
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Exclude
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DE4 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Balloon angioplasty in tibioperoneal interventions for patients with critical limb ischemia ###Abstract: Tibial arterial disease represents the final frontier in the battle against critical limb ischemia (CLI). Isolated infrapopliteal (IP) disease is mainly seen in the elderly (>80 years old), diabetic, and dialysis-dependent patients with CLI. With the development and evolution of catheter-based technology, endovascular therapy (mainly balloon angioplasty) has become the method of choice for revascularization in these patients. The most common challenges are the severely calcified lesion recalcitrant to dilation (as calcium is heterogeneously distributed in the arterial wall) and the long tibial chronic total occlusions. Percutaneous transluminal angioplasty achieves a technically successful result (<30% residual stenosis) in most cases, but it is limited by high restenosis rates. Although several devices have been used in the IP arena (including orbital and directional atherectomy, laser atherectomy, "contact" atherectomy [CROSSER, Bard], and re-entry devices), percutaneous transluminal angioplasty with plain old balloons has been the subject of most studies with several modified iterations, that is, cryoplasty, cutting balloons, focal force balloons, nitinol-"cage"-constrained balloons, tapered balloons, and most recently drug-coated balloons. In this article, we share our current approach to endovascular IP endovascular interventions. We cover the spectrum from pathophysiology, clinical indications, equipment choices, and procedural steps used in our laboratory when treating patients with CLI (which is synonymous with complex anatomy). Regarding what represents the "gold standard" for the treatment of IP disease, a definite answer is currently not available, as multiple studies looking at new generation drug-coated balloons used alone or in combination with different forms of atherectomy are currently under way. We anxiously wait for these results and in the meantime continue to design newer approaches. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Balloon angioplasty in tibioperoneal interventions for patients with critical limb ischemia ###Abstract: Tibial arterial disease represents the final frontier in the battle against critical limb ischemia (CLI). Isolated infrapopliteal (IP) disease is mainly seen in the elderly (>80 years old), diabetic, and dialysis-dependent patients with CLI. With the development and evolution of catheter-based technology, endovascular therapy (mainly balloon angioplasty) has become the method of choice for revascularization in these patients. The most common challenges are the severely calcified lesion recalcitrant to dilation (as calcium is heterogeneously distributed in the arterial wall) and the long tibial chronic total occlusions. Percutaneous transluminal angioplasty achieves a technically successful result (<30% residual stenosis) in most cases, but it is limited by high restenosis rates. Although several devices have been used in the IP arena (including orbital and directional atherectomy, laser atherectomy, "contact" atherectomy [CROSSER, Bard], and re-entry devices), percutaneous transluminal angioplasty with plain old balloons has been the subject of most studies with several modified iterations, that is, cryoplasty, cutting balloons, focal force balloons, nitinol-"cage"-constrained balloons, tapered balloons, and most recently drug-coated balloons. In this article, we share our current approach to endovascular IP endovascular interventions. We cover the spectrum from pathophysiology, clinical indications, equipment choices, and procedural steps used in our laboratory when treating patients with CLI (which is synonymous with complex anatomy). Regarding what represents the "gold standard" for the treatment of IP disease, a definite answer is currently not available, as multiple studies looking at new generation drug-coated balloons used alone or in combination with different forms of atherectomy are currently under way. We anxiously wait for these results and in the meantime continue to design newer approaches. [/INST] Exclude </s>
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Neamtu 2014
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Current concepts on cardiovascular stent devices
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Coronary artery stents used for the treatment of patients with coronary artery disease develop the practice of interventional cardiology after they were first introduced in the mid-1980s. Since then, with dozens of companies involved in the development of new and innovative anti-restenotic drugs, polymeric coatings and stent platforms has made significant progress in this area. Today, the challenge is the conception of the "ideal" coronary stent designed to respond to the patient health difficulty. In this context, the literature in the field is quite dynamic and successful. The aim of this article is to provide a systematic review on the interdisciplinary field literature of the evolution of these medical devices by describing the current status, importance and different types of stents used in clinical practice. After the presentation of cardiovascular problems associated to stenting therapy, the authors describe the bare metal stents, the generations of drug eluting stents and the future in progress directions regarding: the stents based on biodegradable/bioresorbable polymers, polymer-free metal platforms, fully biodegradable scaffolds, as well as drug delivery mediated by stent-targeted magnetic nanoparticles. © 2014 Bentham Science Publishers.
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Exclude
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DE4 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Current concepts on cardiovascular stent devices ###Abstract: Coronary artery stents used for the treatment of patients with coronary artery disease develop the practice of interventional cardiology after they were first introduced in the mid-1980s. Since then, with dozens of companies involved in the development of new and innovative anti-restenotic drugs, polymeric coatings and stent platforms has made significant progress in this area. Today, the challenge is the conception of the "ideal" coronary stent designed to respond to the patient health difficulty. In this context, the literature in the field is quite dynamic and successful. The aim of this article is to provide a systematic review on the interdisciplinary field literature of the evolution of these medical devices by describing the current status, importance and different types of stents used in clinical practice. After the presentation of cardiovascular problems associated to stenting therapy, the authors describe the bare metal stents, the generations of drug eluting stents and the future in progress directions regarding: the stents based on biodegradable/bioresorbable polymers, polymer-free metal platforms, fully biodegradable scaffolds, as well as drug delivery mediated by stent-targeted magnetic nanoparticles. © 2014 Bentham Science Publishers. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Current concepts on cardiovascular stent devices ###Abstract: Coronary artery stents used for the treatment of patients with coronary artery disease develop the practice of interventional cardiology after they were first introduced in the mid-1980s. Since then, with dozens of companies involved in the development of new and innovative anti-restenotic drugs, polymeric coatings and stent platforms has made significant progress in this area. Today, the challenge is the conception of the "ideal" coronary stent designed to respond to the patient health difficulty. In this context, the literature in the field is quite dynamic and successful. The aim of this article is to provide a systematic review on the interdisciplinary field literature of the evolution of these medical devices by describing the current status, importance and different types of stents used in clinical practice. After the presentation of cardiovascular problems associated to stenting therapy, the authors describe the bare metal stents, the generations of drug eluting stents and the future in progress directions regarding: the stents based on biodegradable/bioresorbable polymers, polymer-free metal platforms, fully biodegradable scaffolds, as well as drug delivery mediated by stent-targeted magnetic nanoparticles. © 2014 Bentham Science Publishers. [/INST] Exclude </s>
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Piccoli 2015
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Drug-coated balloon dilation before carotid artery stenting of post-carotid endarterectomy restenosis
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Purpose: To investigate if drug-coated balloon (DCB) predilation may improve the efficacy of carotid artery stenting (CAS) for restenosis after carotid endarterectomy (CEA). Methods: Eighteen consecutive patients (11 men; median age 75 years) with significant restenosis within 24 months of CEA were treated with a paclitaxel-coated DCB prior to CAS. Clinical outcomes and stent patency were systematically appraised. Results: All patients were successfully treated according to this clinical protocol. The only complication occurred in a patient who had a transient ischemic attack during prolonged DCB inflation. At a median follow-up of 18 months, no >50% restenosis was observed on duplex ultrasound scans; however, moderate hyperplasia at the proximal stent edge was found in 4 patients. One patient died at 9 months from a myocardial infarction. Conclusion: Despite the small sample size and in keeping with the historically high risk of recurrent restenosis after CAS for CEA restenosis, this case series suggests that DCB dilation followed by CAS for postsurgical restenosis is feasible, safe, and may be associated with favorable clinical outcomes at midterm follow-up.
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Include
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Review Full Text
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon dilation before carotid artery stenting of post-carotid endarterectomy restenosis ###Abstract: Purpose: To investigate if drug-coated balloon (DCB) predilation may improve the efficacy of carotid artery stenting (CAS) for restenosis after carotid endarterectomy (CEA). Methods: Eighteen consecutive patients (11 men; median age 75 years) with significant restenosis within 24 months of CEA were treated with a paclitaxel-coated DCB prior to CAS. Clinical outcomes and stent patency were systematically appraised. Results: All patients were successfully treated according to this clinical protocol. The only complication occurred in a patient who had a transient ischemic attack during prolonged DCB inflation. At a median follow-up of 18 months, no >50% restenosis was observed on duplex ultrasound scans; however, moderate hyperplasia at the proximal stent edge was found in 4 patients. One patient died at 9 months from a myocardial infarction. Conclusion: Despite the small sample size and in keeping with the historically high risk of recurrent restenosis after CAS for CEA restenosis, this case series suggests that DCB dilation followed by CAS for postsurgical restenosis is feasible, safe, and may be associated with favorable clinical outcomes at midterm follow-up. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon dilation before carotid artery stenting of post-carotid endarterectomy restenosis ###Abstract: Purpose: To investigate if drug-coated balloon (DCB) predilation may improve the efficacy of carotid artery stenting (CAS) for restenosis after carotid endarterectomy (CEA). Methods: Eighteen consecutive patients (11 men; median age 75 years) with significant restenosis within 24 months of CEA were treated with a paclitaxel-coated DCB prior to CAS. Clinical outcomes and stent patency were systematically appraised. Results: All patients were successfully treated according to this clinical protocol. The only complication occurred in a patient who had a transient ischemic attack during prolonged DCB inflation. At a median follow-up of 18 months, no >50% restenosis was observed on duplex ultrasound scans; however, moderate hyperplasia at the proximal stent edge was found in 4 patients. One patient died at 9 months from a myocardial infarction. Conclusion: Despite the small sample size and in keeping with the historically high risk of recurrent restenosis after CAS for CEA restenosis, this case series suggests that DCB dilation followed by CAS for postsurgical restenosis is feasible, safe, and may be associated with favorable clinical outcomes at midterm follow-up. [/INST] Include </s>
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Piorkowski 2015
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Twelve-month experience with the GORE(®) TIGRIS(®) Vascular Stent in the superficial femoral and popliteal arteries
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Aim: The aim of this paper was to report the continued mid-term follow-up of the first patients worldwide treated with the GORE(®) TIGRIS(®) Vascular Stent, a dual component stent consisting of a nitinol wire frame combined with a fluoropolymer-interconnecting structure. Methods: From December 2011 until November 2012, 32 consecutive patients (20 men, mean age 72.8 years) with 40 atherosclerotic femoropopliteal lesions (5% occlusions) underwent angioplasty and implantation of a GORE(®) TIGRIS(®) Vascular Stent. The patients were scheduled for follow-up at 3, 6 and 12 months after stent implantation for duplex ultrasound and assessment of Rutherford-Becker class (RBC) and Ankle-Brachial Index (ABI). Here we report the completed 6-month follow-up and, for the first time, a 12-month follow-up. Results: The median follow-up was 418 days. During the 12-month follow-up 4 patients died. Restenosis or reocclusion of the stent in this time period was observed in 5 lesions (12.5%), resulting in a cumulative primary patency rate of 85.5±6.0%.The ABI increased pre-interventionally from 0.65±0.18 to 0.91±0.18 (P<0.0001) at the 12-month visit. The median RBC improved from 3 to 1 (P<0.0001). No stent thrombosis related to discontinuation of dual antiplatelet therapy 4 weeks after the index procedure was observed. Conclusion: The mid-term follow-up of the dual component GORE(®) TIGRIS(®) Vascular Stent showed promising results with high 12-month primary patency rates after femoropopliteal endovascular interventions. These first clinical data are very promising compared to other stent concepts in the superficial femoral and popliteal artery.
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Exclude
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DE3 - Incorrect Device
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Twelve-month experience with the GORE(®) TIGRIS(®) Vascular Stent in the superficial femoral and popliteal arteries ###Abstract: Aim: The aim of this paper was to report the continued mid-term follow-up of the first patients worldwide treated with the GORE(®) TIGRIS(®) Vascular Stent, a dual component stent consisting of a nitinol wire frame combined with a fluoropolymer-interconnecting structure. Methods: From December 2011 until November 2012, 32 consecutive patients (20 men, mean age 72.8 years) with 40 atherosclerotic femoropopliteal lesions (5% occlusions) underwent angioplasty and implantation of a GORE(®) TIGRIS(®) Vascular Stent. The patients were scheduled for follow-up at 3, 6 and 12 months after stent implantation for duplex ultrasound and assessment of Rutherford-Becker class (RBC) and Ankle-Brachial Index (ABI). Here we report the completed 6-month follow-up and, for the first time, a 12-month follow-up. Results: The median follow-up was 418 days. During the 12-month follow-up 4 patients died. Restenosis or reocclusion of the stent in this time period was observed in 5 lesions (12.5%), resulting in a cumulative primary patency rate of 85.5±6.0%.The ABI increased pre-interventionally from 0.65±0.18 to 0.91±0.18 (P<0.0001) at the 12-month visit. The median RBC improved from 3 to 1 (P<0.0001). No stent thrombosis related to discontinuation of dual antiplatelet therapy 4 weeks after the index procedure was observed. Conclusion: The mid-term follow-up of the dual component GORE(®) TIGRIS(®) Vascular Stent showed promising results with high 12-month primary patency rates after femoropopliteal endovascular interventions. These first clinical data are very promising compared to other stent concepts in the superficial femoral and popliteal artery. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Twelve-month experience with the GORE(®) TIGRIS(®) Vascular Stent in the superficial femoral and popliteal arteries ###Abstract: Aim: The aim of this paper was to report the continued mid-term follow-up of the first patients worldwide treated with the GORE(®) TIGRIS(®) Vascular Stent, a dual component stent consisting of a nitinol wire frame combined with a fluoropolymer-interconnecting structure. Methods: From December 2011 until November 2012, 32 consecutive patients (20 men, mean age 72.8 years) with 40 atherosclerotic femoropopliteal lesions (5% occlusions) underwent angioplasty and implantation of a GORE(®) TIGRIS(®) Vascular Stent. The patients were scheduled for follow-up at 3, 6 and 12 months after stent implantation for duplex ultrasound and assessment of Rutherford-Becker class (RBC) and Ankle-Brachial Index (ABI). Here we report the completed 6-month follow-up and, for the first time, a 12-month follow-up. Results: The median follow-up was 418 days. During the 12-month follow-up 4 patients died. Restenosis or reocclusion of the stent in this time period was observed in 5 lesions (12.5%), resulting in a cumulative primary patency rate of 85.5±6.0%.The ABI increased pre-interventionally from 0.65±0.18 to 0.91±0.18 (P<0.0001) at the 12-month visit. The median RBC improved from 3 to 1 (P<0.0001). No stent thrombosis related to discontinuation of dual antiplatelet therapy 4 weeks after the index procedure was observed. Conclusion: The mid-term follow-up of the dual component GORE(®) TIGRIS(®) Vascular Stent showed promising results with high 12-month primary patency rates after femoropopliteal endovascular interventions. These first clinical data are very promising compared to other stent concepts in the superficial femoral and popliteal artery. [/INST] Exclude </s>
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Razzouk 2013
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In-stent restenosis in the superficial femoral artery
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As the number of endovascular peripheral arterial interventions is increasing nationwide, so is the rate of observed in-stent restenosis, specifically in the superficial femoral artery. A paucity of literature is available regarding the pathophysiology, risk factors, and therapies associated with in-stent restenosis of the superficial femoral artery. This article summarizes the accumulated knowledge on these topics and sheds some light on the prospects for future therapies. © 2013 Elsevier Inc. All rights reserved.
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Exclude
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DE12 - Wrong Article Type
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: In-stent restenosis in the superficial femoral artery ###Abstract: As the number of endovascular peripheral arterial interventions is increasing nationwide, so is the rate of observed in-stent restenosis, specifically in the superficial femoral artery. A paucity of literature is available regarding the pathophysiology, risk factors, and therapies associated with in-stent restenosis of the superficial femoral artery. This article summarizes the accumulated knowledge on these topics and sheds some light on the prospects for future therapies. © 2013 Elsevier Inc. All rights reserved. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: In-stent restenosis in the superficial femoral artery ###Abstract: As the number of endovascular peripheral arterial interventions is increasing nationwide, so is the rate of observed in-stent restenosis, specifically in the superficial femoral artery. A paucity of literature is available regarding the pathophysiology, risk factors, and therapies associated with in-stent restenosis of the superficial femoral artery. This article summarizes the accumulated knowledge on these topics and sheds some light on the prospects for future therapies. © 2013 Elsevier Inc. All rights reserved. [/INST] Exclude </s>
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Sang 2015
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Acute two-vessel occlusion due to simultaneous very late stent thrombosis following sirolimus-eluting stent implantation: A case report and review of the literature
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Include
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Review Full Text
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Acute two-vessel occlusion due to simultaneous very late stent thrombosis following sirolimus-eluting stent implantation: A case report and review of the literature ###Abstract: None [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Acute two-vessel occlusion due to simultaneous very late stent thrombosis following sirolimus-eluting stent implantation: A case report and review of the literature ###Abstract: None [/INST] Include </s>
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Sangiorgi 2012
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Drug-eluting balloons for carotid in-stent restenosis: Can this technology deliver the goods?
| null |
Exclude
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DE12 - Wrong Article Type
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting balloons for carotid in-stent restenosis: Can this technology deliver the goods? ###Abstract: None [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting balloons for carotid in-stent restenosis: Can this technology deliver the goods? ###Abstract: None [/INST] Exclude </s>
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Scheer 2014
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Combination of rotational atherothrombectomy and paclitaxel-coated angioplasty for femoropopliteal occlusion
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Objective: The rotational atherothrombectomy with Straub Rotarex® is a safe and efficient treatment of acute/subactute vascular occlusions. The purpose of this study was to evaluate the benefit of paclitaxel-coated angioplasty after rotational atherothrombectomy over an observation period of six months.Materials and methods: Overall, 29 patients were treated with the Rotarex catheter in combination with paclitaxel-coated angioplasty. All patients had acute/subacute and chronic occlusions of the superficial femoral artery (SFA) and/or popliteal arteries. The ankle-brachial index (ABI) was detected before the intervention, after the procedure, and after six months. Also clinical examination and ultrasound scans were done in the observation period.Results: There were no technical failures. The ABI shows a significant increase from 0.52 ± 0.17 to 0.91 ± 0.25 in the follow-up. By ultrasound examina-tion, there were found two (6.9%) restenoses during the follow-up. There was one dissection during the intervention (3.5%).CoConclusioion: The rotational atherothrombectomy in combination with paclitaxel-coated angioplasty might be an effective and safe method with a promising low rate of restenosis at six months.
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Include
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Review Full Text
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Combination of rotational atherothrombectomy and paclitaxel-coated angioplasty for femoropopliteal occlusion ###Abstract: Objective: The rotational atherothrombectomy with Straub Rotarex® is a safe and efficient treatment of acute/subactute vascular occlusions. The purpose of this study was to evaluate the benefit of paclitaxel-coated angioplasty after rotational atherothrombectomy over an observation period of six months.Materials and methods: Overall, 29 patients were treated with the Rotarex catheter in combination with paclitaxel-coated angioplasty. All patients had acute/subacute and chronic occlusions of the superficial femoral artery (SFA) and/or popliteal arteries. The ankle-brachial index (ABI) was detected before the intervention, after the procedure, and after six months. Also clinical examination and ultrasound scans were done in the observation period.Results: There were no technical failures. The ABI shows a significant increase from 0.52 ± 0.17 to 0.91 ± 0.25 in the follow-up. By ultrasound examina-tion, there were found two (6.9%) restenoses during the follow-up. There was one dissection during the intervention (3.5%).CoConclusioion: The rotational atherothrombectomy in combination with paclitaxel-coated angioplasty might be an effective and safe method with a promising low rate of restenosis at six months. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Combination of rotational atherothrombectomy and paclitaxel-coated angioplasty for femoropopliteal occlusion ###Abstract: Objective: The rotational atherothrombectomy with Straub Rotarex® is a safe and efficient treatment of acute/subactute vascular occlusions. The purpose of this study was to evaluate the benefit of paclitaxel-coated angioplasty after rotational atherothrombectomy over an observation period of six months.Materials and methods: Overall, 29 patients were treated with the Rotarex catheter in combination with paclitaxel-coated angioplasty. All patients had acute/subacute and chronic occlusions of the superficial femoral artery (SFA) and/or popliteal arteries. The ankle-brachial index (ABI) was detected before the intervention, after the procedure, and after six months. Also clinical examination and ultrasound scans were done in the observation period.Results: There were no technical failures. The ABI shows a significant increase from 0.52 ± 0.17 to 0.91 ± 0.25 in the follow-up. By ultrasound examina-tion, there were found two (6.9%) restenoses during the follow-up. There was one dissection during the intervention (3.5%).CoConclusioion: The rotational atherothrombectomy in combination with paclitaxel-coated angioplasty might be an effective and safe method with a promising low rate of restenosis at six months. [/INST] Include </s>
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Scheller 2011
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Drug-coated balloons - Potential coronary vascular applications
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One of the most innovative fields in modern medical research is the percutaneous transluminal treatment of vascular disease. During the last few decades considerable advances have been made in intravascular interventions for the treatment of coronary and peripheral arterial disease. However, long-term outcome remains an area of concern in many applications. Restenosis is still a challenge in endovascular medicine and has thus been referred to as the Achilles' heel of percutaneous intervention. Therefore, novel strategies have been developed to overcome this problem. These include drug-eluting stents and the more recently introduced non-stent-based local drug delivery systems, in particular the drug-coated balloon. The results of several pre-clinical and clinical studies indicate that short-term exposure of injured arteries to paclitaxel delivered from regular angioplasty balloons may be sufficient to reduce late lumen loss and restenosis rates during the critical period after angioplasty of diseased coronary and peripheral arteries. Although the number of published trials and patients treated is still limited, the available data seem to prove that restenosis inhibition by immediate drug release is feasible. This article reviews the potential applications of the drug-coated balloon in coronary vascular disease. © TOUCH BRIEFINGS 2011.
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Exclude
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DE4 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloons - Potential coronary vascular applications ###Abstract: One of the most innovative fields in modern medical research is the percutaneous transluminal treatment of vascular disease. During the last few decades considerable advances have been made in intravascular interventions for the treatment of coronary and peripheral arterial disease. However, long-term outcome remains an area of concern in many applications. Restenosis is still a challenge in endovascular medicine and has thus been referred to as the Achilles' heel of percutaneous intervention. Therefore, novel strategies have been developed to overcome this problem. These include drug-eluting stents and the more recently introduced non-stent-based local drug delivery systems, in particular the drug-coated balloon. The results of several pre-clinical and clinical studies indicate that short-term exposure of injured arteries to paclitaxel delivered from regular angioplasty balloons may be sufficient to reduce late lumen loss and restenosis rates during the critical period after angioplasty of diseased coronary and peripheral arteries. Although the number of published trials and patients treated is still limited, the available data seem to prove that restenosis inhibition by immediate drug release is feasible. This article reviews the potential applications of the drug-coated balloon in coronary vascular disease. © TOUCH BRIEFINGS 2011. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloons - Potential coronary vascular applications ###Abstract: One of the most innovative fields in modern medical research is the percutaneous transluminal treatment of vascular disease. During the last few decades considerable advances have been made in intravascular interventions for the treatment of coronary and peripheral arterial disease. However, long-term outcome remains an area of concern in many applications. Restenosis is still a challenge in endovascular medicine and has thus been referred to as the Achilles' heel of percutaneous intervention. Therefore, novel strategies have been developed to overcome this problem. These include drug-eluting stents and the more recently introduced non-stent-based local drug delivery systems, in particular the drug-coated balloon. The results of several pre-clinical and clinical studies indicate that short-term exposure of injured arteries to paclitaxel delivered from regular angioplasty balloons may be sufficient to reduce late lumen loss and restenosis rates during the critical period after angioplasty of diseased coronary and peripheral arteries. Although the number of published trials and patients treated is still limited, the available data seem to prove that restenosis inhibition by immediate drug release is feasible. This article reviews the potential applications of the drug-coated balloon in coronary vascular disease. © TOUCH BRIEFINGS 2011. [/INST] Exclude </s>
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Schnorr 2013
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Drug-coated balloons and their place in treating peripheral arterial disease
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Drug-coated balloons (DCB) have emerged as an additional treatment option for managing restenosis in lesions of the superficial femoral artery and of the infrapopliteal arterial bed. Relatively limited data are available on the use of DCB in these lesions, but scientific evidence is mounting. In five randomized controlled trials, late lumen loss 6 months after the intervention was found to be markedly lower in patients treated with paclitaxel-coated balloons (PCB) compared with uncoated balloons. Different types of PCB are currently on the market. It remains to be seen how different coatings affect the performance of PCB and clinical outcome. Long-term results are also awaited. In this review, the authors describe the components of DCB and how they affect performance. Then, the authors provide an overview of clinical results obtained with PCB in the superficial femoral artery and below the knee, and finally the article gives an outlook on the future of DCB in peripheral arterial disease. © 2013 Expert Reviews Ltd.
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Exclude
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DE12 - Wrong Article Type
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloons and their place in treating peripheral arterial disease ###Abstract: Drug-coated balloons (DCB) have emerged as an additional treatment option for managing restenosis in lesions of the superficial femoral artery and of the infrapopliteal arterial bed. Relatively limited data are available on the use of DCB in these lesions, but scientific evidence is mounting. In five randomized controlled trials, late lumen loss 6 months after the intervention was found to be markedly lower in patients treated with paclitaxel-coated balloons (PCB) compared with uncoated balloons. Different types of PCB are currently on the market. It remains to be seen how different coatings affect the performance of PCB and clinical outcome. Long-term results are also awaited. In this review, the authors describe the components of DCB and how they affect performance. Then, the authors provide an overview of clinical results obtained with PCB in the superficial femoral artery and below the knee, and finally the article gives an outlook on the future of DCB in peripheral arterial disease. © 2013 Expert Reviews Ltd. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloons and their place in treating peripheral arterial disease ###Abstract: Drug-coated balloons (DCB) have emerged as an additional treatment option for managing restenosis in lesions of the superficial femoral artery and of the infrapopliteal arterial bed. Relatively limited data are available on the use of DCB in these lesions, but scientific evidence is mounting. In five randomized controlled trials, late lumen loss 6 months after the intervention was found to be markedly lower in patients treated with paclitaxel-coated balloons (PCB) compared with uncoated balloons. Different types of PCB are currently on the market. It remains to be seen how different coatings affect the performance of PCB and clinical outcome. Long-term results are also awaited. In this review, the authors describe the components of DCB and how they affect performance. Then, the authors provide an overview of clinical results obtained with PCB in the superficial femoral artery and below the knee, and finally the article gives an outlook on the future of DCB in peripheral arterial disease. © 2013 Expert Reviews Ltd. [/INST] Exclude </s>
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Seol 2009
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Multiple sequential complications after sirolimus-eluting stent implantation: Very late stent thrombosis, stent fracture, in-stent restenosis, and peri-stent aneurysm
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A 55-year-old male patient presented with an acute myocardial infarction. A sirolimus-eluting stent (SES) was implanted in the proximal left anterior descending artery (LAD). Eight months later, there was a newly developed distal LAD lesion. An additional SES was implanted. Twenty-eight months after the index procedure of primary coronary intervention, the electrocardiogram showed ST elevation in the precordial leads and an emergency coronary angiogram showed diffuse stent thrombosis (ST) in the proximal LAD. Thirty-four months after the index procedure, coronary angiography showed a large peri-stent coronary aneurysm in the proximal LAD and focal in-stent restenosis (ISR) at the proximal edge of the distal LAD stent. On fluoroscopy, a fracture was noted in the middle part of the distal SES. A zotarolimus-eluting stent (ZES) was deployed and overlapped the restenosis and fracture sites. Forty months after the index procedure, there were no changes in the size of the aneurysm or in the other stent complications including the fracture and restenosis. At present, the patient has remained asymptomatic for eight months. Copyright © 2009 The Korean Society of Cardiology.
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Exclude
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DE4 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Multiple sequential complications after sirolimus-eluting stent implantation: Very late stent thrombosis, stent fracture, in-stent restenosis, and peri-stent aneurysm ###Abstract: A 55-year-old male patient presented with an acute myocardial infarction. A sirolimus-eluting stent (SES) was implanted in the proximal left anterior descending artery (LAD). Eight months later, there was a newly developed distal LAD lesion. An additional SES was implanted. Twenty-eight months after the index procedure of primary coronary intervention, the electrocardiogram showed ST elevation in the precordial leads and an emergency coronary angiogram showed diffuse stent thrombosis (ST) in the proximal LAD. Thirty-four months after the index procedure, coronary angiography showed a large peri-stent coronary aneurysm in the proximal LAD and focal in-stent restenosis (ISR) at the proximal edge of the distal LAD stent. On fluoroscopy, a fracture was noted in the middle part of the distal SES. A zotarolimus-eluting stent (ZES) was deployed and overlapped the restenosis and fracture sites. Forty months after the index procedure, there were no changes in the size of the aneurysm or in the other stent complications including the fracture and restenosis. At present, the patient has remained asymptomatic for eight months. Copyright © 2009 The Korean Society of Cardiology. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Multiple sequential complications after sirolimus-eluting stent implantation: Very late stent thrombosis, stent fracture, in-stent restenosis, and peri-stent aneurysm ###Abstract: A 55-year-old male patient presented with an acute myocardial infarction. A sirolimus-eluting stent (SES) was implanted in the proximal left anterior descending artery (LAD). Eight months later, there was a newly developed distal LAD lesion. An additional SES was implanted. Twenty-eight months after the index procedure of primary coronary intervention, the electrocardiogram showed ST elevation in the precordial leads and an emergency coronary angiogram showed diffuse stent thrombosis (ST) in the proximal LAD. Thirty-four months after the index procedure, coronary angiography showed a large peri-stent coronary aneurysm in the proximal LAD and focal in-stent restenosis (ISR) at the proximal edge of the distal LAD stent. On fluoroscopy, a fracture was noted in the middle part of the distal SES. A zotarolimus-eluting stent (ZES) was deployed and overlapped the restenosis and fracture sites. Forty months after the index procedure, there were no changes in the size of the aneurysm or in the other stent complications including the fracture and restenosis. At present, the patient has remained asymptomatic for eight months. Copyright © 2009 The Korean Society of Cardiology. [/INST] Exclude </s>
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Sgueglia 2011
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Simultaneous inflation of two drug-eluting balloons for the treatment of coronary bifurcation restenosis: A concept series
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Coronary bifurcation restenoses are especially challenging lesions to treat. In this report, four cases are described in which an innovative approach consisting of the simultaneous inflation of two drug-eluting balloons has been successfully applied to treat different kinds of bifurcation restenoses following both provisional and complex stenting strategies. These selected cases illustrate the concept and the advantages of a kissing drug-eluting balloon strategy for the treatment of virtually any kind of bifurcation restenosis.
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Include
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Review Full Text
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Simultaneous inflation of two drug-eluting balloons for the treatment of coronary bifurcation restenosis: A concept series ###Abstract: Coronary bifurcation restenoses are especially challenging lesions to treat. In this report, four cases are described in which an innovative approach consisting of the simultaneous inflation of two drug-eluting balloons has been successfully applied to treat different kinds of bifurcation restenoses following both provisional and complex stenting strategies. These selected cases illustrate the concept and the advantages of a kissing drug-eluting balloon strategy for the treatment of virtually any kind of bifurcation restenosis. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Simultaneous inflation of two drug-eluting balloons for the treatment of coronary bifurcation restenosis: A concept series ###Abstract: Coronary bifurcation restenoses are especially challenging lesions to treat. In this report, four cases are described in which an innovative approach consisting of the simultaneous inflation of two drug-eluting balloons has been successfully applied to treat different kinds of bifurcation restenoses following both provisional and complex stenting strategies. These selected cases illustrate the concept and the advantages of a kissing drug-eluting balloon strategy for the treatment of virtually any kind of bifurcation restenosis. [/INST] Include </s>
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Sgueglia 2011
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Kissing inflation is feasible with all second-generation drug-eluting balloons
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Objective: To assess the feasibility of kissing second-generation drug-eluting balloons (DEB), which have better mechanical properties than the first-generation DEB, in order to optimize provisional bare-metal stenting (BMS) when treating coronary bifurcation lesions in patients with contraindication to drug-eluting stents. Methods: Consecutive patients with anticipated low compliance to dual antiplatelet therapy who are undergoing provisional stenting with an open-cell design BMS and final kissing balloon with second-generation DEB were enrolled in this feasibility study. Angiographic success and procedural success (i.e., angiographic success in absence of in hospital major cardiovascular events) were registered. Clinical follow-up was also attempted in all patients. Results: A total of 14 patients (mean age 66±9 years, nine men) participated on the study. The DEB used were SeQuent Please (B. Braun Melsungen, Berlin, Germany) in six patients, In.Pact Falcon (Medtronic Invatec, Roncadelle, Italy) in four patients, New Dior (Eurocor, Bonn, Germany) in two patients and Pantera Lux (Biotronik, Berlin, Germany) in another two patients. All procedures, but one, were performed by transradial access through a 6-French high-flow guiding catheter. True bifurcation was present in 50% of the patients. Angiographic and procedural success was obtained in all patients. At a mean follow-up of 234±81 days, all contacted patients were asymptomatic and free from major adverse cardiac events (including cardiac death, nonfatal myocardial infarction and target bifurcation revascularization). Conclusion: At the advent of dedicated bifurcation stents, kissing DEB appears safe and effective and can be used to implement innovative, simpler, safer and possibly more effective bifurcation techniques. These remarkable results have laid the ground for an ongoing prospective registry of the kissing DEB technique (KISSING DEBBIE study, ClinicalTrials.gov NCT01009996). © 2011 Elsevier Inc.
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Exclude
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DE4 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Kissing inflation is feasible with all second-generation drug-eluting balloons ###Abstract: Objective: To assess the feasibility of kissing second-generation drug-eluting balloons (DEB), which have better mechanical properties than the first-generation DEB, in order to optimize provisional bare-metal stenting (BMS) when treating coronary bifurcation lesions in patients with contraindication to drug-eluting stents. Methods: Consecutive patients with anticipated low compliance to dual antiplatelet therapy who are undergoing provisional stenting with an open-cell design BMS and final kissing balloon with second-generation DEB were enrolled in this feasibility study. Angiographic success and procedural success (i.e., angiographic success in absence of in hospital major cardiovascular events) were registered. Clinical follow-up was also attempted in all patients. Results: A total of 14 patients (mean age 66±9 years, nine men) participated on the study. The DEB used were SeQuent Please (B. Braun Melsungen, Berlin, Germany) in six patients, In.Pact Falcon (Medtronic Invatec, Roncadelle, Italy) in four patients, New Dior (Eurocor, Bonn, Germany) in two patients and Pantera Lux (Biotronik, Berlin, Germany) in another two patients. All procedures, but one, were performed by transradial access through a 6-French high-flow guiding catheter. True bifurcation was present in 50% of the patients. Angiographic and procedural success was obtained in all patients. At a mean follow-up of 234±81 days, all contacted patients were asymptomatic and free from major adverse cardiac events (including cardiac death, nonfatal myocardial infarction and target bifurcation revascularization). Conclusion: At the advent of dedicated bifurcation stents, kissing DEB appears safe and effective and can be used to implement innovative, simpler, safer and possibly more effective bifurcation techniques. These remarkable results have laid the ground for an ongoing prospective registry of the kissing DEB technique (KISSING DEBBIE study, ClinicalTrials.gov NCT01009996). © 2011 Elsevier Inc. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Kissing inflation is feasible with all second-generation drug-eluting balloons ###Abstract: Objective: To assess the feasibility of kissing second-generation drug-eluting balloons (DEB), which have better mechanical properties than the first-generation DEB, in order to optimize provisional bare-metal stenting (BMS) when treating coronary bifurcation lesions in patients with contraindication to drug-eluting stents. Methods: Consecutive patients with anticipated low compliance to dual antiplatelet therapy who are undergoing provisional stenting with an open-cell design BMS and final kissing balloon with second-generation DEB were enrolled in this feasibility study. Angiographic success and procedural success (i.e., angiographic success in absence of in hospital major cardiovascular events) were registered. Clinical follow-up was also attempted in all patients. Results: A total of 14 patients (mean age 66±9 years, nine men) participated on the study. The DEB used were SeQuent Please (B. Braun Melsungen, Berlin, Germany) in six patients, In.Pact Falcon (Medtronic Invatec, Roncadelle, Italy) in four patients, New Dior (Eurocor, Bonn, Germany) in two patients and Pantera Lux (Biotronik, Berlin, Germany) in another two patients. All procedures, but one, were performed by transradial access through a 6-French high-flow guiding catheter. True bifurcation was present in 50% of the patients. Angiographic and procedural success was obtained in all patients. At a mean follow-up of 234±81 days, all contacted patients were asymptomatic and free from major adverse cardiac events (including cardiac death, nonfatal myocardial infarction and target bifurcation revascularization). Conclusion: At the advent of dedicated bifurcation stents, kissing DEB appears safe and effective and can be used to implement innovative, simpler, safer and possibly more effective bifurcation techniques. These remarkable results have laid the ground for an ongoing prospective registry of the kissing DEB technique (KISSING DEBBIE study, ClinicalTrials.gov NCT01009996). © 2011 Elsevier Inc. [/INST] Exclude </s>
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Shammas 2015
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Should We Routinely Stent the Femoropopliteal Artery? An Interventionalist's Perspective
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Stenting of femoropopliteal (FP) arterial disease is currently the most common strategy adopted by endovascular specialists. Several randomized trials have shown that stenting with nitinol self-expanding stents leads to less restenosis on intermediate-term and long-term follow-up when compared with plain old balloon angioplasty (POBA) and provisional stenting. In this overview, we present the pros and cons of primary stenting of FP arteries vs alternative approaches including provisional stenting following POBA, atherectomy and/or drug-coated balloons, and how these initial non-stent strategies play a significant role in treating FP arterial disease.
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Exclude
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DE12 - Wrong Article Type
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Should We Routinely Stent the Femoropopliteal Artery? An Interventionalist's Perspective ###Abstract: Stenting of femoropopliteal (FP) arterial disease is currently the most common strategy adopted by endovascular specialists. Several randomized trials have shown that stenting with nitinol self-expanding stents leads to less restenosis on intermediate-term and long-term follow-up when compared with plain old balloon angioplasty (POBA) and provisional stenting. In this overview, we present the pros and cons of primary stenting of FP arteries vs alternative approaches including provisional stenting following POBA, atherectomy and/or drug-coated balloons, and how these initial non-stent strategies play a significant role in treating FP arterial disease. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Should We Routinely Stent the Femoropopliteal Artery? An Interventionalist's Perspective ###Abstract: Stenting of femoropopliteal (FP) arterial disease is currently the most common strategy adopted by endovascular specialists. Several randomized trials have shown that stenting with nitinol self-expanding stents leads to less restenosis on intermediate-term and long-term follow-up when compared with plain old balloon angioplasty (POBA) and provisional stenting. In this overview, we present the pros and cons of primary stenting of FP arteries vs alternative approaches including provisional stenting following POBA, atherectomy and/or drug-coated balloons, and how these initial non-stent strategies play a significant role in treating FP arterial disease. [/INST] Exclude </s>
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Shand 2011
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Novel stent and drug elution technologies
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To address concerns of late and very late stent thrombosis associated with first generation drug-eluting stent technology, novel approaches are being tested including stents with bioabsorbable polymers (including Biomatrix Flex™, Nobori™ and Synergy™), polymer-free drug delivery systems (including Biofreedom™ and Yukon®) and drug-eluting balloons (including Sequent Please™, Dior® II and Pantera Lux™). This article reviews the key clinical data evaluating these approaches and describes future directions for technology development. © 2011 Future Medicine Ltd.
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Exclude
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DE12 - Wrong Article Type
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Novel stent and drug elution technologies ###Abstract: To address concerns of late and very late stent thrombosis associated with first generation drug-eluting stent technology, novel approaches are being tested including stents with bioabsorbable polymers (including Biomatrix Flex™, Nobori™ and Synergy™), polymer-free drug delivery systems (including Biofreedom™ and Yukon®) and drug-eluting balloons (including Sequent Please™, Dior® II and Pantera Lux™). This article reviews the key clinical data evaluating these approaches and describes future directions for technology development. © 2011 Future Medicine Ltd. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Novel stent and drug elution technologies ###Abstract: To address concerns of late and very late stent thrombosis associated with first generation drug-eluting stent technology, novel approaches are being tested including stents with bioabsorbable polymers (including Biomatrix Flex™, Nobori™ and Synergy™), polymer-free drug delivery systems (including Biofreedom™ and Yukon®) and drug-eluting balloons (including Sequent Please™, Dior® II and Pantera Lux™). This article reviews the key clinical data evaluating these approaches and describes future directions for technology development. © 2011 Future Medicine Ltd. [/INST] Exclude </s>
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Sharma 2011
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Local drug delivery for percutaneous coronary intervention
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Since the first successful coronary angioplasty by Andreas Grüntzig in 1977, the field of percutaneous coronary intervention (PCI) has expanded rapidly. Rapid technological refinement has seen equipment and complementary pharmacotherapy to improve the outcome of PCI evolve dramatically, driven by clinical need and enormous market forces. The ideal intervention should expand the vessel lumen without inflicting endothelial injury, and provide local drug delivery to prevent subsequent acute thrombosis and neointimal hyperplasia. Drug eluting stents, once regarded as the "gold standard" in PCI, and established as the treatment of choice for nearly a decade, remain limited in their performance by important risks of in-stent restenosis and late stent thrombosis. In this review, we discuss need for local drug therapy as an adjunct to angioplasty and present exciting new technological advances to deliver local pharmacotherapy to the coronary artery, which will hopefully overcome some of the limitations of DES and may represent the way forward in coronary intervention. © 2010 Elsevier Inc. All rights reserved.
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Exclude
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DE4 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Local drug delivery for percutaneous coronary intervention ###Abstract: Since the first successful coronary angioplasty by Andreas Grüntzig in 1977, the field of percutaneous coronary intervention (PCI) has expanded rapidly. Rapid technological refinement has seen equipment and complementary pharmacotherapy to improve the outcome of PCI evolve dramatically, driven by clinical need and enormous market forces. The ideal intervention should expand the vessel lumen without inflicting endothelial injury, and provide local drug delivery to prevent subsequent acute thrombosis and neointimal hyperplasia. Drug eluting stents, once regarded as the "gold standard" in PCI, and established as the treatment of choice for nearly a decade, remain limited in their performance by important risks of in-stent restenosis and late stent thrombosis. In this review, we discuss need for local drug therapy as an adjunct to angioplasty and present exciting new technological advances to deliver local pharmacotherapy to the coronary artery, which will hopefully overcome some of the limitations of DES and may represent the way forward in coronary intervention. © 2010 Elsevier Inc. All rights reserved. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Local drug delivery for percutaneous coronary intervention ###Abstract: Since the first successful coronary angioplasty by Andreas Grüntzig in 1977, the field of percutaneous coronary intervention (PCI) has expanded rapidly. Rapid technological refinement has seen equipment and complementary pharmacotherapy to improve the outcome of PCI evolve dramatically, driven by clinical need and enormous market forces. The ideal intervention should expand the vessel lumen without inflicting endothelial injury, and provide local drug delivery to prevent subsequent acute thrombosis and neointimal hyperplasia. Drug eluting stents, once regarded as the "gold standard" in PCI, and established as the treatment of choice for nearly a decade, remain limited in their performance by important risks of in-stent restenosis and late stent thrombosis. In this review, we discuss need for local drug therapy as an adjunct to angioplasty and present exciting new technological advances to deliver local pharmacotherapy to the coronary artery, which will hopefully overcome some of the limitations of DES and may represent the way forward in coronary intervention. © 2010 Elsevier Inc. All rights reserved. [/INST] Exclude </s>
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Silingardi 2014
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Mechanical thrombectomy in proximal subclavian artery in-stent occlusion
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Purpose: Mechanical thrombectomy is an established tool for endovascular therapy of acute/chronic in-stent occlusions of the lower extremities, especially for the superficial femoral artery. The authors report the use of the Rotarex catheter system for an in-stent proximal subclavian occlusion. Case presentation: A 51-year-old female patient with previous multiple attempts at left subclavian revascularization; primary endovascular stenting at the origin of the subclavian artery occluded at 3 months, and a carotid-subclavian bypass was placed distally to the stent. After 6 months from the first treatment, the patient was readmitted with an acute left arm ischemia and full occlusion of the bypass was confirmed at computed tomography angiography. An anterograde thrombectomy for in-stent restenosis, together with PTA with a drug-eluting balloon was performed in the subclavian artery with confirmed patency at 6 months. Conclusion: Mechanical thrombectomy together with drug-eluting balloon PTA for in-stent occlusion or restenosis of the subclavian artery could be a promising procedure with a lower invasivity and risk with respect to surgical options. © 2013 Japanese Association of Cardiovascular Intervention and Therapeutics.
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Exclude
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DE4 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Mechanical thrombectomy in proximal subclavian artery in-stent occlusion ###Abstract: Purpose: Mechanical thrombectomy is an established tool for endovascular therapy of acute/chronic in-stent occlusions of the lower extremities, especially for the superficial femoral artery. The authors report the use of the Rotarex catheter system for an in-stent proximal subclavian occlusion. Case presentation: A 51-year-old female patient with previous multiple attempts at left subclavian revascularization; primary endovascular stenting at the origin of the subclavian artery occluded at 3 months, and a carotid-subclavian bypass was placed distally to the stent. After 6 months from the first treatment, the patient was readmitted with an acute left arm ischemia and full occlusion of the bypass was confirmed at computed tomography angiography. An anterograde thrombectomy for in-stent restenosis, together with PTA with a drug-eluting balloon was performed in the subclavian artery with confirmed patency at 6 months. Conclusion: Mechanical thrombectomy together with drug-eluting balloon PTA for in-stent occlusion or restenosis of the subclavian artery could be a promising procedure with a lower invasivity and risk with respect to surgical options. © 2013 Japanese Association of Cardiovascular Intervention and Therapeutics. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Mechanical thrombectomy in proximal subclavian artery in-stent occlusion ###Abstract: Purpose: Mechanical thrombectomy is an established tool for endovascular therapy of acute/chronic in-stent occlusions of the lower extremities, especially for the superficial femoral artery. The authors report the use of the Rotarex catheter system for an in-stent proximal subclavian occlusion. Case presentation: A 51-year-old female patient with previous multiple attempts at left subclavian revascularization; primary endovascular stenting at the origin of the subclavian artery occluded at 3 months, and a carotid-subclavian bypass was placed distally to the stent. After 6 months from the first treatment, the patient was readmitted with an acute left arm ischemia and full occlusion of the bypass was confirmed at computed tomography angiography. An anterograde thrombectomy for in-stent restenosis, together with PTA with a drug-eluting balloon was performed in the subclavian artery with confirmed patency at 6 months. Conclusion: Mechanical thrombectomy together with drug-eluting balloon PTA for in-stent occlusion or restenosis of the subclavian artery could be a promising procedure with a lower invasivity and risk with respect to surgical options. © 2013 Japanese Association of Cardiovascular Intervention and Therapeutics. [/INST] Exclude </s>
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Stahlhoff 2015
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Drug-eluting vs standard balloon angioplasty for iliac stent restenosis: Midterm results
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Purpose: To assess the effectiveness of drug-eluting balloon (DEB) angioplasty for the treatment of iliac artery in-stent restenosis (ISR). Methods: Data from 18 patients (mean age 59.3±9.6 years; 11 men) treated with DEB for iliac ISR between October 2009 and August 2013 were retrospectively evaluated and compared with a control group of 22 patients (mean age 66.7±11.8 years; 16 men) treated with standard balloon angioplasty (BA). Primary endpoint of the study was the primary patency rate at 12 months. Secondary endpoints were 30-day and overall mortality, sustained clinical improvement [ankle-brachial index (ABI) and Rutherford category] and clinically driven target lesion revascularization (TLR). Followup examinations were performed by clinical examination, color duplex ultrasound, and ABI measurement at 12 months. Results: Mean length of the 21 lesions in the DEB group was 27.1±19.2 mm vs 20.0±11.4 mm for the 25 lesions in the BA group (p=0.508), while the grade of restenosis was 70.4%±18.4% and 64.0%±16.1% (p=0.255), respectively. Primary patency rates were 90.5% vs 85.7% at 6 months and 71.4% vs 75.6% at 12 months for DEB and BA, respectively (p=0.784). Five BA patients died during follow-up for reasons unrelated to the procedure, while no patient in the DEB group died (p=0.035). In both groups, Rutherford category and ABI significantly improved compared to pretreatment levels; there were no differences between the groups regarding these variables (p=0.367 and p=0.898, respectively). The TLR rate was 28.6% (6/21) in the DEB group and 20.0% (4/20) in the BA cohort (p=0.434). Conclusion: Treatment of iliac ISR using DEBs is a safe procedure, with results comparable to BA treatment. Because of the limited number of patients in this study, further investigation of a larger cohort with longer follow-up is needed to define the role of DEBs in the treatment of iliac ISR.
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Include
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Review Full Text
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting vs standard balloon angioplasty for iliac stent restenosis: Midterm results ###Abstract: Purpose: To assess the effectiveness of drug-eluting balloon (DEB) angioplasty for the treatment of iliac artery in-stent restenosis (ISR). Methods: Data from 18 patients (mean age 59.3±9.6 years; 11 men) treated with DEB for iliac ISR between October 2009 and August 2013 were retrospectively evaluated and compared with a control group of 22 patients (mean age 66.7±11.8 years; 16 men) treated with standard balloon angioplasty (BA). Primary endpoint of the study was the primary patency rate at 12 months. Secondary endpoints were 30-day and overall mortality, sustained clinical improvement [ankle-brachial index (ABI) and Rutherford category] and clinically driven target lesion revascularization (TLR). Followup examinations were performed by clinical examination, color duplex ultrasound, and ABI measurement at 12 months. Results: Mean length of the 21 lesions in the DEB group was 27.1±19.2 mm vs 20.0±11.4 mm for the 25 lesions in the BA group (p=0.508), while the grade of restenosis was 70.4%±18.4% and 64.0%±16.1% (p=0.255), respectively. Primary patency rates were 90.5% vs 85.7% at 6 months and 71.4% vs 75.6% at 12 months for DEB and BA, respectively (p=0.784). Five BA patients died during follow-up for reasons unrelated to the procedure, while no patient in the DEB group died (p=0.035). In both groups, Rutherford category and ABI significantly improved compared to pretreatment levels; there were no differences between the groups regarding these variables (p=0.367 and p=0.898, respectively). The TLR rate was 28.6% (6/21) in the DEB group and 20.0% (4/20) in the BA cohort (p=0.434). Conclusion: Treatment of iliac ISR using DEBs is a safe procedure, with results comparable to BA treatment. Because of the limited number of patients in this study, further investigation of a larger cohort with longer follow-up is needed to define the role of DEBs in the treatment of iliac ISR. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting vs standard balloon angioplasty for iliac stent restenosis: Midterm results ###Abstract: Purpose: To assess the effectiveness of drug-eluting balloon (DEB) angioplasty for the treatment of iliac artery in-stent restenosis (ISR). Methods: Data from 18 patients (mean age 59.3±9.6 years; 11 men) treated with DEB for iliac ISR between October 2009 and August 2013 were retrospectively evaluated and compared with a control group of 22 patients (mean age 66.7±11.8 years; 16 men) treated with standard balloon angioplasty (BA). Primary endpoint of the study was the primary patency rate at 12 months. Secondary endpoints were 30-day and overall mortality, sustained clinical improvement [ankle-brachial index (ABI) and Rutherford category] and clinically driven target lesion revascularization (TLR). Followup examinations were performed by clinical examination, color duplex ultrasound, and ABI measurement at 12 months. Results: Mean length of the 21 lesions in the DEB group was 27.1±19.2 mm vs 20.0±11.4 mm for the 25 lesions in the BA group (p=0.508), while the grade of restenosis was 70.4%±18.4% and 64.0%±16.1% (p=0.255), respectively. Primary patency rates were 90.5% vs 85.7% at 6 months and 71.4% vs 75.6% at 12 months for DEB and BA, respectively (p=0.784). Five BA patients died during follow-up for reasons unrelated to the procedure, while no patient in the DEB group died (p=0.035). In both groups, Rutherford category and ABI significantly improved compared to pretreatment levels; there were no differences between the groups regarding these variables (p=0.367 and p=0.898, respectively). The TLR rate was 28.6% (6/21) in the DEB group and 20.0% (4/20) in the BA cohort (p=0.434). Conclusion: Treatment of iliac ISR using DEBs is a safe procedure, with results comparable to BA treatment. Because of the limited number of patients in this study, further investigation of a larger cohort with longer follow-up is needed to define the role of DEBs in the treatment of iliac ISR. [/INST] Include </s>
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Stavroulakis 2015
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Combined directional atherectomy and drug-eluting balloon angioplasty for isolated popliteal artery lesions in patients with peripheral artery disease
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Purpose: To evaluate the midterm results of combined directional atherectomy (DA) and drug-eluting balloon (DEB) angioplasty for atherosclerotic lesions of the popliteal artery. Methods: In a single-arm, prospective study, 21 patients (mean age 63±16 years; 16 men) with isolated popliteal artery lesions were enrolled and underwent treatment with combined DA and DEB angioplasty under filter protection between October 2009 and February 2014. The majority (18, 86%) presented with lifestyle-limiting intermittent claudication and 3 with critical limb ischemia. Fifteen (71%) target sites were de novo lesions; 4 were occlusions. The main outcome was primary patency; secondary outcomes were technical success, secondary patency, and early and midterm morbidity and mortality. Results: The TurboHawk atherectomy device was used in 15 (71%) patients and the SilverHawk peripheral plaque excision system in the remaining 6 patients. The In.Pact Admiral/Pacific DEB was used in the majority of cases (15, 71%). The technical success rate was 90% (n=19). One flow-limiting dissection was treated with bailout stenting. Complications included a perforation of the popliteal artery and 2 puncture site hematomas; there was no distal embolic event. The mean follow-up was 18±12 months. Two restenoses were retreated successfully. Kaplan-Meier estimates of primary patency at 12 and 18 months were 95% and 90%, respectively; the secondary patency was 100%. One (5%) patient died in follow-up. None of the patients had an amputation. Conclusion: In this prospective single-arm study, the combined therapy of DA and DEB angioplasty for popliteal artery lesions showed promising midterm performance. The combination of DA and DEB may, in highly selected patients, overcome the challenges presented by the mobility of the knee joint.
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Include
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Review Full Text
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Combined directional atherectomy and drug-eluting balloon angioplasty for isolated popliteal artery lesions in patients with peripheral artery disease ###Abstract: Purpose: To evaluate the midterm results of combined directional atherectomy (DA) and drug-eluting balloon (DEB) angioplasty for atherosclerotic lesions of the popliteal artery. Methods: In a single-arm, prospective study, 21 patients (mean age 63±16 years; 16 men) with isolated popliteal artery lesions were enrolled and underwent treatment with combined DA and DEB angioplasty under filter protection between October 2009 and February 2014. The majority (18, 86%) presented with lifestyle-limiting intermittent claudication and 3 with critical limb ischemia. Fifteen (71%) target sites were de novo lesions; 4 were occlusions. The main outcome was primary patency; secondary outcomes were technical success, secondary patency, and early and midterm morbidity and mortality. Results: The TurboHawk atherectomy device was used in 15 (71%) patients and the SilverHawk peripheral plaque excision system in the remaining 6 patients. The In.Pact Admiral/Pacific DEB was used in the majority of cases (15, 71%). The technical success rate was 90% (n=19). One flow-limiting dissection was treated with bailout stenting. Complications included a perforation of the popliteal artery and 2 puncture site hematomas; there was no distal embolic event. The mean follow-up was 18±12 months. Two restenoses were retreated successfully. Kaplan-Meier estimates of primary patency at 12 and 18 months were 95% and 90%, respectively; the secondary patency was 100%. One (5%) patient died in follow-up. None of the patients had an amputation. Conclusion: In this prospective single-arm study, the combined therapy of DA and DEB angioplasty for popliteal artery lesions showed promising midterm performance. The combination of DA and DEB may, in highly selected patients, overcome the challenges presented by the mobility of the knee joint. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Combined directional atherectomy and drug-eluting balloon angioplasty for isolated popliteal artery lesions in patients with peripheral artery disease ###Abstract: Purpose: To evaluate the midterm results of combined directional atherectomy (DA) and drug-eluting balloon (DEB) angioplasty for atherosclerotic lesions of the popliteal artery. Methods: In a single-arm, prospective study, 21 patients (mean age 63±16 years; 16 men) with isolated popliteal artery lesions were enrolled and underwent treatment with combined DA and DEB angioplasty under filter protection between October 2009 and February 2014. The majority (18, 86%) presented with lifestyle-limiting intermittent claudication and 3 with critical limb ischemia. Fifteen (71%) target sites were de novo lesions; 4 were occlusions. The main outcome was primary patency; secondary outcomes were technical success, secondary patency, and early and midterm morbidity and mortality. Results: The TurboHawk atherectomy device was used in 15 (71%) patients and the SilverHawk peripheral plaque excision system in the remaining 6 patients. The In.Pact Admiral/Pacific DEB was used in the majority of cases (15, 71%). The technical success rate was 90% (n=19). One flow-limiting dissection was treated with bailout stenting. Complications included a perforation of the popliteal artery and 2 puncture site hematomas; there was no distal embolic event. The mean follow-up was 18±12 months. Two restenoses were retreated successfully. Kaplan-Meier estimates of primary patency at 12 and 18 months were 95% and 90%, respectively; the secondary patency was 100%. One (5%) patient died in follow-up. None of the patients had an amputation. Conclusion: In this prospective single-arm study, the combined therapy of DA and DEB angioplasty for popliteal artery lesions showed promising midterm performance. The combination of DA and DEB may, in highly selected patients, overcome the challenges presented by the mobility of the knee joint. [/INST] Include </s>
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Stella 2010
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Drug-eluting balloons and bifurcations, a new future?
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Exclude
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DE12 - Wrong Article Type
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting balloons and bifurcations, a new future? ###Abstract: None [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting balloons and bifurcations, a new future? ###Abstract: None [/INST] Exclude </s>
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Surhonne 2015
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Successful retrieval of fractured pressure wire tip (FFR) by hybrid technique
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Coronary angiography and angioplasty are relatively safe procedures but not without complications. We report an interesting case of effort angina taken for angioplasty of the LCX and assessment of fractional flow reserve (FFR) for the LAD artery lesion in which the tip of the pressure wire was broken and embolised to the LCX while trying to retrieve it. This is the first case report using a hybrid technique with a slip catheter for the successful retrieval of a fractured FFR wire.
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Exclude
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DE4 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Successful retrieval of fractured pressure wire tip (FFR) by hybrid technique ###Abstract: Coronary angiography and angioplasty are relatively safe procedures but not without complications. We report an interesting case of effort angina taken for angioplasty of the LCX and assessment of fractional flow reserve (FFR) for the LAD artery lesion in which the tip of the pressure wire was broken and embolised to the LCX while trying to retrieve it. This is the first case report using a hybrid technique with a slip catheter for the successful retrieval of a fractured FFR wire. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Successful retrieval of fractured pressure wire tip (FFR) by hybrid technique ###Abstract: Coronary angiography and angioplasty are relatively safe procedures but not without complications. We report an interesting case of effort angina taken for angioplasty of the LCX and assessment of fractional flow reserve (FFR) for the LAD artery lesion in which the tip of the pressure wire was broken and embolised to the LCX while trying to retrieve it. This is the first case report using a hybrid technique with a slip catheter for the successful retrieval of a fractured FFR wire. [/INST] Exclude </s>
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Swinnen 2015
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Paclitaxel drug-eluting balloons to recurrent in-stent stenoses in autogenous dialysis fistulas: A retrospective study
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Purpose: To assess the effect of the Medtronic paclitaxel drug-eluting balloon (DEB) on re-intervention to in-stent stenoses in autogenous dialysis arteriovenous fistulas (AVFs). Background: AVF is the optimum haemodialysis access. The commonest problem is stenosis, preventing maturation, causing inadequate dialysis or precipitating occlusion. Conventional angioplasty has a high recurrence rate. Successful drug elution in the coronary circulation led us to use DEBs in recurrent AVF stenoses since 2010. Methods: This is a retrospective study, based on prospective audit data, using DEBs on recurrent in-stent stenotic lesions in the AVF circuit of our haemodialysis population. To analyse the effect of DEBs on re-intervention, we created two Kaplan–Meier curves. The first curve compares the last “disease-free-interval” pre-DEB intervention to the first “disease-free interval” post-DEB, giving us “re-intervention-free percentage at 12 months” pre- and post-DEB. The second curve takes into account the multiple pre- and post-DEB interventions to the index lesion, and uses a marginal proportional hazards model to estimate the hazard ratio for “DEBpresent vs. DEBabsent”. Results: From 1 September 2010 to 1 December 2013, we treated 625 AVF stenoses with endovascular techniques. In 86 of these stenoses, DEBs were used. Of the 86 DEB interventions, 37 were included for this study, 49 were excluded. In the study group, there was a significant difference in “re-intervention-free percentage at 12 months” before and after DEB: 19% vs. 69%. The hazard ratio for “DEBpresent” vs. “DEBabsent” was 0.23 (95% CI 0.14 to 0.36, p<0.001). Conclusions: This retrospective study suggests that DEBs significantly reduce re-intervention on recurrent in-stent AVF stenoses.
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Include
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Review Full Text
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel drug-eluting balloons to recurrent in-stent stenoses in autogenous dialysis fistulas: A retrospective study ###Abstract: Purpose: To assess the effect of the Medtronic paclitaxel drug-eluting balloon (DEB) on re-intervention to in-stent stenoses in autogenous dialysis arteriovenous fistulas (AVFs). Background: AVF is the optimum haemodialysis access. The commonest problem is stenosis, preventing maturation, causing inadequate dialysis or precipitating occlusion. Conventional angioplasty has a high recurrence rate. Successful drug elution in the coronary circulation led us to use DEBs in recurrent AVF stenoses since 2010. Methods: This is a retrospective study, based on prospective audit data, using DEBs on recurrent in-stent stenotic lesions in the AVF circuit of our haemodialysis population. To analyse the effect of DEBs on re-intervention, we created two Kaplan–Meier curves. The first curve compares the last “disease-free-interval” pre-DEB intervention to the first “disease-free interval” post-DEB, giving us “re-intervention-free percentage at 12 months” pre- and post-DEB. The second curve takes into account the multiple pre- and post-DEB interventions to the index lesion, and uses a marginal proportional hazards model to estimate the hazard ratio for “DEBpresent vs. DEBabsent”. Results: From 1 September 2010 to 1 December 2013, we treated 625 AVF stenoses with endovascular techniques. In 86 of these stenoses, DEBs were used. Of the 86 DEB interventions, 37 were included for this study, 49 were excluded. In the study group, there was a significant difference in “re-intervention-free percentage at 12 months” before and after DEB: 19% vs. 69%. The hazard ratio for “DEBpresent” vs. “DEBabsent” was 0.23 (95% CI 0.14 to 0.36, p<0.001). Conclusions: This retrospective study suggests that DEBs significantly reduce re-intervention on recurrent in-stent AVF stenoses. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel drug-eluting balloons to recurrent in-stent stenoses in autogenous dialysis fistulas: A retrospective study ###Abstract: Purpose: To assess the effect of the Medtronic paclitaxel drug-eluting balloon (DEB) on re-intervention to in-stent stenoses in autogenous dialysis arteriovenous fistulas (AVFs). Background: AVF is the optimum haemodialysis access. The commonest problem is stenosis, preventing maturation, causing inadequate dialysis or precipitating occlusion. Conventional angioplasty has a high recurrence rate. Successful drug elution in the coronary circulation led us to use DEBs in recurrent AVF stenoses since 2010. Methods: This is a retrospective study, based on prospective audit data, using DEBs on recurrent in-stent stenotic lesions in the AVF circuit of our haemodialysis population. To analyse the effect of DEBs on re-intervention, we created two Kaplan–Meier curves. The first curve compares the last “disease-free-interval” pre-DEB intervention to the first “disease-free interval” post-DEB, giving us “re-intervention-free percentage at 12 months” pre- and post-DEB. The second curve takes into account the multiple pre- and post-DEB interventions to the index lesion, and uses a marginal proportional hazards model to estimate the hazard ratio for “DEBpresent vs. DEBabsent”. Results: From 1 September 2010 to 1 December 2013, we treated 625 AVF stenoses with endovascular techniques. In 86 of these stenoses, DEBs were used. Of the 86 DEB interventions, 37 were included for this study, 49 were excluded. In the study group, there was a significant difference in “re-intervention-free percentage at 12 months” before and after DEB: 19% vs. 69%. The hazard ratio for “DEBpresent” vs. “DEBabsent” was 0.23 (95% CI 0.14 to 0.36, p<0.001). Conclusions: This retrospective study suggests that DEBs significantly reduce re-intervention on recurrent in-stent AVF stenoses. [/INST] Include </s>
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Takama 2014
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Failure of a balloon to deflate during post dilatation in a coronary artery
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Entrapment of nondeflated balloon is a rare complication of percutaneous coronary intervention. Sometimes it has hazardous potentials for the patient. We experienced a rare complication of percutaneous coronary intervention (PCI) caused by a defective balloon. We reported this experience and simple bailout technique.
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Include
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Review Full Text
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Failure of a balloon to deflate during post dilatation in a coronary artery ###Abstract: Entrapment of nondeflated balloon is a rare complication of percutaneous coronary intervention. Sometimes it has hazardous potentials for the patient. We experienced a rare complication of percutaneous coronary intervention (PCI) caused by a defective balloon. We reported this experience and simple bailout technique. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Failure of a balloon to deflate during post dilatation in a coronary artery ###Abstract: Entrapment of nondeflated balloon is a rare complication of percutaneous coronary intervention. Sometimes it has hazardous potentials for the patient. We experienced a rare complication of percutaneous coronary intervention (PCI) caused by a defective balloon. We reported this experience and simple bailout technique. [/INST] Include </s>
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Teleb 2014
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Endovascular management of intracranial atherosclerosis
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Include
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Review Full Text
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Endovascular management of intracranial atherosclerosis ###Abstract: None [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Endovascular management of intracranial atherosclerosis ###Abstract: None [/INST] Include </s>
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Tepe 2015
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Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease 12-month results from the IN.PACT SFA randomized Trial
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Background: Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease. Methods and Results: The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94±4.89 and 8.81±5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedurerelated deaths and no major amputations. Conclusions: In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease 12-month results from the IN.PACT SFA randomized Trial ###Abstract: Background: Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease. Methods and Results: The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94±4.89 and 8.81±5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedurerelated deaths and no major amputations. Conclusions: In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease 12-month results from the IN.PACT SFA randomized Trial ###Abstract: Background: Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease. Methods and Results: The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94±4.89 and 8.81±5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedurerelated deaths and no major amputations. Conclusions: In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and [/INST] Include </s>
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Thomas 2014
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Vasculitis resulting from a superficial femoral artery angioplasty with a paclitaxel-eluting balloon
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Drug-eluting balloons (DEBs) coated with the antiproliferative agent paclitaxel may improve primary patency by reducing recurrent luminal stenosis. A proportion of the active drug and excipient coating are known to embolize distally, but until now, there have been no reports of adverse events resulting from their use. We report an unusual case of a painful nodular, biopsy specimen-proven vasculitic rash that afflicted the ipsilateral lower limb of a patient after superficial femoral artery treatment with a DEB. This adverse event may have implications for the use of DEB in this and other vascular territories. © 2014 by the Society for Vascular Surgery.
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Include
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Review Full Text
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Vasculitis resulting from a superficial femoral artery angioplasty with a paclitaxel-eluting balloon ###Abstract: Drug-eluting balloons (DEBs) coated with the antiproliferative agent paclitaxel may improve primary patency by reducing recurrent luminal stenosis. A proportion of the active drug and excipient coating are known to embolize distally, but until now, there have been no reports of adverse events resulting from their use. We report an unusual case of a painful nodular, biopsy specimen-proven vasculitic rash that afflicted the ipsilateral lower limb of a patient after superficial femoral artery treatment with a DEB. This adverse event may have implications for the use of DEB in this and other vascular territories. © 2014 by the Society for Vascular Surgery. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Vasculitis resulting from a superficial femoral artery angioplasty with a paclitaxel-eluting balloon ###Abstract: Drug-eluting balloons (DEBs) coated with the antiproliferative agent paclitaxel may improve primary patency by reducing recurrent luminal stenosis. A proportion of the active drug and excipient coating are known to embolize distally, but until now, there have been no reports of adverse events resulting from their use. We report an unusual case of a painful nodular, biopsy specimen-proven vasculitic rash that afflicted the ipsilateral lower limb of a patient after superficial femoral artery treatment with a DEB. This adverse event may have implications for the use of DEB in this and other vascular territories. © 2014 by the Society for Vascular Surgery. [/INST] Include </s>
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Vales 2013
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Successful expansion of an underexpanded stent by rotational atherectomy
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The current routine use of intracoronary stents in percutaneous coronary intervention (PCI) has significantly reduced rates of restenosis, compared with balloon angioplasty alone. On the contrary, small post-stenting luminal dimensions due to undilatable, heavily calcified plaques have repeatedly been shown to significantly increase the rates of in-stent restenosis. Rotational atherectomy of lesions is an alternative method to facilitate PCI and prevent underexpansion of stents, when balloon angioplasty fails to successfully dilate a lesion. Stentablation, using rotational atherectomy to expand underexpanded stents deployed in heavily calcified plaques, has also been reported. We report a case via the transradial approach of rotational-atherectomy-facilitated PCI of in-stent restenosis of a severely underexpanded stent due to a heavily calcified plaque. We review the literature and suggest rotational atherectomy may have a role in treating a refractory, severely underexpanded stent caused by a heavily calcified plaque through various proposed mechanisms. Copyright © 2013 by Thieme Medical Publishers, Inc.
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Exclude
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DE4 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Successful expansion of an underexpanded stent by rotational atherectomy ###Abstract: The current routine use of intracoronary stents in percutaneous coronary intervention (PCI) has significantly reduced rates of restenosis, compared with balloon angioplasty alone. On the contrary, small post-stenting luminal dimensions due to undilatable, heavily calcified plaques have repeatedly been shown to significantly increase the rates of in-stent restenosis. Rotational atherectomy of lesions is an alternative method to facilitate PCI and prevent underexpansion of stents, when balloon angioplasty fails to successfully dilate a lesion. Stentablation, using rotational atherectomy to expand underexpanded stents deployed in heavily calcified plaques, has also been reported. We report a case via the transradial approach of rotational-atherectomy-facilitated PCI of in-stent restenosis of a severely underexpanded stent due to a heavily calcified plaque. We review the literature and suggest rotational atherectomy may have a role in treating a refractory, severely underexpanded stent caused by a heavily calcified plaque through various proposed mechanisms. Copyright © 2013 by Thieme Medical Publishers, Inc. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Successful expansion of an underexpanded stent by rotational atherectomy ###Abstract: The current routine use of intracoronary stents in percutaneous coronary intervention (PCI) has significantly reduced rates of restenosis, compared with balloon angioplasty alone. On the contrary, small post-stenting luminal dimensions due to undilatable, heavily calcified plaques have repeatedly been shown to significantly increase the rates of in-stent restenosis. Rotational atherectomy of lesions is an alternative method to facilitate PCI and prevent underexpansion of stents, when balloon angioplasty fails to successfully dilate a lesion. Stentablation, using rotational atherectomy to expand underexpanded stents deployed in heavily calcified plaques, has also been reported. We report a case via the transradial approach of rotational-atherectomy-facilitated PCI of in-stent restenosis of a severely underexpanded stent due to a heavily calcified plaque. We review the literature and suggest rotational atherectomy may have a role in treating a refractory, severely underexpanded stent caused by a heavily calcified plaque through various proposed mechanisms. Copyright © 2013 by Thieme Medical Publishers, Inc. [/INST] Exclude </s>
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Van Den Berg 2012
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Endovascular treatment of in-stent restenosis using excimer laser angioplasty and drug eluting balloons
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In-stent restenosis after endovascular treatment of stenotic and occlusive disease of the infrainguinal arteries is still a clinical challenge. In this paper an overview of the current status of drug-eluting balloon technology and results of clinical trials with drug-eluting balloon angioplasty is given. Furthermore a case series of 10 patients with in-stent restenosis that were treated with excimer laser angioplasty and drug eluting balloons is described. In this case series the mean lesion length treated was 115 mm, and the mean time to occurrence of restenosis after initial treatment was 7.2 months. At a mean follow-up (of all patients) of 7.6 months no target vessel revascularization was seen. In 7 patients that had Duplex and/or angiographic control (mean follow-up 7 months) no signs of neointimal hyperplasia were demonstrated. These short-term data compare favorable to results obtained with standard balloon angioplasty and cutting-balloon angioplasty. Long-term follow-up is necessary to define the role of combined excimer laser and drug-eluting balloon angioplasty in the treatment of in-stent restenosis further.
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Include
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Review Full Text
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Endovascular treatment of in-stent restenosis using excimer laser angioplasty and drug eluting balloons ###Abstract: In-stent restenosis after endovascular treatment of stenotic and occlusive disease of the infrainguinal arteries is still a clinical challenge. In this paper an overview of the current status of drug-eluting balloon technology and results of clinical trials with drug-eluting balloon angioplasty is given. Furthermore a case series of 10 patients with in-stent restenosis that were treated with excimer laser angioplasty and drug eluting balloons is described. In this case series the mean lesion length treated was 115 mm, and the mean time to occurrence of restenosis after initial treatment was 7.2 months. At a mean follow-up (of all patients) of 7.6 months no target vessel revascularization was seen. In 7 patients that had Duplex and/or angiographic control (mean follow-up 7 months) no signs of neointimal hyperplasia were demonstrated. These short-term data compare favorable to results obtained with standard balloon angioplasty and cutting-balloon angioplasty. Long-term follow-up is necessary to define the role of combined excimer laser and drug-eluting balloon angioplasty in the treatment of in-stent restenosis further. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Endovascular treatment of in-stent restenosis using excimer laser angioplasty and drug eluting balloons ###Abstract: In-stent restenosis after endovascular treatment of stenotic and occlusive disease of the infrainguinal arteries is still a clinical challenge. In this paper an overview of the current status of drug-eluting balloon technology and results of clinical trials with drug-eluting balloon angioplasty is given. Furthermore a case series of 10 patients with in-stent restenosis that were treated with excimer laser angioplasty and drug eluting balloons is described. In this case series the mean lesion length treated was 115 mm, and the mean time to occurrence of restenosis after initial treatment was 7.2 months. At a mean follow-up (of all patients) of 7.6 months no target vessel revascularization was seen. In 7 patients that had Duplex and/or angiographic control (mean follow-up 7 months) no signs of neointimal hyperplasia were demonstrated. These short-term data compare favorable to results obtained with standard balloon angioplasty and cutting-balloon angioplasty. Long-term follow-up is necessary to define the role of combined excimer laser and drug-eluting balloon angioplasty in the treatment of in-stent restenosis further. [/INST] Include </s>
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Venero 2013
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A completely fractured zotarolimus-eluting stent in an aortocoronary saphenous vein bypass graft
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Drug-eluting stents (DES) have significantly improved the rate of target vessel revascularization in comparison with bare metal stents. DES fracture was not reported in multicenter randomized clinical trials, but several case reports of DES fracture have been published, mostly with sirolimus-eluting stents. DES fracture is associated with stent restenosis and thrombosis. We report a zotarolimus-eluting stent fracture in an aortocoronary saphenous vein graft (SVG) bypass. The patient presented with chest pain and a non-ST-elevation myocardial infarction. He underwent cardiac catheterization that showed a complete fracture of a zotarolimus-eluting stent in the ostium of a sequential SVG to the diagonal and obtuse coronary arteries. His management included coronary angioplasty and retrieval of the proximal fractured segment. We discuss the potential causes for this stent fracture and suggest caution when using a DES in an ostial location of a SVG bypass, especially in a highly mobile vessel. © 2012 Wiley Periodicals, Inc.
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Exclude
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DE4 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: A completely fractured zotarolimus-eluting stent in an aortocoronary saphenous vein bypass graft ###Abstract: Drug-eluting stents (DES) have significantly improved the rate of target vessel revascularization in comparison with bare metal stents. DES fracture was not reported in multicenter randomized clinical trials, but several case reports of DES fracture have been published, mostly with sirolimus-eluting stents. DES fracture is associated with stent restenosis and thrombosis. We report a zotarolimus-eluting stent fracture in an aortocoronary saphenous vein graft (SVG) bypass. The patient presented with chest pain and a non-ST-elevation myocardial infarction. He underwent cardiac catheterization that showed a complete fracture of a zotarolimus-eluting stent in the ostium of a sequential SVG to the diagonal and obtuse coronary arteries. His management included coronary angioplasty and retrieval of the proximal fractured segment. We discuss the potential causes for this stent fracture and suggest caution when using a DES in an ostial location of a SVG bypass, especially in a highly mobile vessel. © 2012 Wiley Periodicals, Inc. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: A completely fractured zotarolimus-eluting stent in an aortocoronary saphenous vein bypass graft ###Abstract: Drug-eluting stents (DES) have significantly improved the rate of target vessel revascularization in comparison with bare metal stents. DES fracture was not reported in multicenter randomized clinical trials, but several case reports of DES fracture have been published, mostly with sirolimus-eluting stents. DES fracture is associated with stent restenosis and thrombosis. We report a zotarolimus-eluting stent fracture in an aortocoronary saphenous vein graft (SVG) bypass. The patient presented with chest pain and a non-ST-elevation myocardial infarction. He underwent cardiac catheterization that showed a complete fracture of a zotarolimus-eluting stent in the ostium of a sequential SVG to the diagonal and obtuse coronary arteries. His management included coronary angioplasty and retrieval of the proximal fractured segment. We discuss the potential causes for this stent fracture and suggest caution when using a DES in an ostial location of a SVG bypass, especially in a highly mobile vessel. © 2012 Wiley Periodicals, Inc. [/INST] Exclude </s>
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Virga 2014
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Drug-eluting balloons for the treatment of the superficial femoral artery in-stent restenosis: 2-year follow-up
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Objectives: The aim of this prospective registry was to evaluate the safety and efficacy at 2-year follow-up of the use of drug-eluting balloons (DEBs) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR). Background: The use of DEBs for the treatment of SFA ISR is associated with a satisfactory primary patency rate at 1 year, but no data are available for longer follow-up. Unfortunately, when DEBs were used to treat SFA de novo lesions, the occurrence of restenosis increased by 50% between the first and the second years of follow-up. Methods: From December 2009 to December 2010, 39 consecutive patients underwent percutaneous transluminal angioplasty of SFA ISR at our institution (Clinica Montevergine, Mercogliano, Italy). All patients underwent conventional SFA percutaneous transluminal angioplasty and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic Inc., Minneapolis, Minnesota). Patients were evaluated for up to 24 months. Results: During follow-up, 1 patient died of heart failure and another of sudden death, for a 2-years rate of cardiovascular mortality rate of 5.12 %. The primary patency rate at 2 years was 70.3% (11 of 37 patients experienced restenosis recurrence at 2-year follow-up). The treatment of complex ISR lesions (classes II and III) was associated with an increased rate of recurrent restenosis compared with class I (33.3 % and 36.3 % vs. 12.5%; p = 0.05). Conclusions: The data suggest that adjunctive use of DEBs for the treatment of SFA ISR is a safe and effective therapeutic strategy up to 2 years of follow-up. © 2014 by the American College of Cardiology Foundation.
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Include
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Review Full Text
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting balloons for the treatment of the superficial femoral artery in-stent restenosis: 2-year follow-up ###Abstract: Objectives: The aim of this prospective registry was to evaluate the safety and efficacy at 2-year follow-up of the use of drug-eluting balloons (DEBs) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR). Background: The use of DEBs for the treatment of SFA ISR is associated with a satisfactory primary patency rate at 1 year, but no data are available for longer follow-up. Unfortunately, when DEBs were used to treat SFA de novo lesions, the occurrence of restenosis increased by 50% between the first and the second years of follow-up. Methods: From December 2009 to December 2010, 39 consecutive patients underwent percutaneous transluminal angioplasty of SFA ISR at our institution (Clinica Montevergine, Mercogliano, Italy). All patients underwent conventional SFA percutaneous transluminal angioplasty and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic Inc., Minneapolis, Minnesota). Patients were evaluated for up to 24 months. Results: During follow-up, 1 patient died of heart failure and another of sudden death, for a 2-years rate of cardiovascular mortality rate of 5.12 %. The primary patency rate at 2 years was 70.3% (11 of 37 patients experienced restenosis recurrence at 2-year follow-up). The treatment of complex ISR lesions (classes II and III) was associated with an increased rate of recurrent restenosis compared with class I (33.3 % and 36.3 % vs. 12.5%; p = 0.05). Conclusions: The data suggest that adjunctive use of DEBs for the treatment of SFA ISR is a safe and effective therapeutic strategy up to 2 years of follow-up. © 2014 by the American College of Cardiology Foundation. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting balloons for the treatment of the superficial femoral artery in-stent restenosis: 2-year follow-up ###Abstract: Objectives: The aim of this prospective registry was to evaluate the safety and efficacy at 2-year follow-up of the use of drug-eluting balloons (DEBs) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR). Background: The use of DEBs for the treatment of SFA ISR is associated with a satisfactory primary patency rate at 1 year, but no data are available for longer follow-up. Unfortunately, when DEBs were used to treat SFA de novo lesions, the occurrence of restenosis increased by 50% between the first and the second years of follow-up. Methods: From December 2009 to December 2010, 39 consecutive patients underwent percutaneous transluminal angioplasty of SFA ISR at our institution (Clinica Montevergine, Mercogliano, Italy). All patients underwent conventional SFA percutaneous transluminal angioplasty and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic Inc., Minneapolis, Minnesota). Patients were evaluated for up to 24 months. Results: During follow-up, 1 patient died of heart failure and another of sudden death, for a 2-years rate of cardiovascular mortality rate of 5.12 %. The primary patency rate at 2 years was 70.3% (11 of 37 patients experienced restenosis recurrence at 2-year follow-up). The treatment of complex ISR lesions (classes II and III) was associated with an increased rate of recurrent restenosis compared with class I (33.3 % and 36.3 % vs. 12.5%; p = 0.05). Conclusions: The data suggest that adjunctive use of DEBs for the treatment of SFA ISR is a safe and effective therapeutic strategy up to 2 years of follow-up. © 2014 by the American College of Cardiology Foundation. [/INST] Include </s>
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Werk 2012a
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Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: Evidence from the randomized PACIFIER trial
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Background-Peripheral percutaneous transluminal angioplasty is fraught with a substantial risk of restenosis and reintervention. A drug-eluting balloon (DEB) based on a novel coating was compared with uncoated balloons in patients undergoing femoro-popliteal percutaneous transluminal angioplasty. Methods and Results-Patients with symptomatic femoro-popliteal atherosclerotic disease undergoing percutaneous transluminal angioplasty were randomized to paclitaxel-coated IN.PACT Pacific or uncoated Pacific balloons. The primary end point was late lumen loss at 6 months assessed by blinded angiographic corelab quantitative analyses. Secondary end points were binary restenosis and Rutherford class change at 6 months, and target lesion revascularization plus major adverse clinical events (major adverse events=death, target limb amputation, or target lesion revascularization) at 6 and 12 months. Eighty-five patients (91 cases=interventional procedures) were randomized in 3 hospitals (44 to DEB and 47 to uncoated balloons). Average lesion length was 7.0±5.3 and 6.6±5.5cm for DEB and control arm, respectively. Procedural success was obtained in all cases. Six-month quantitative angiography showed that DEB were associated with significantly lower late lumen loss (-0.01mm [95% CI, -0.29; 0.26] versus 0.65mm [0.37; 0.93], P=0.001) and fewer binary restenoses (3 [8.6%] versus 11 [32.4%], P=0.01). This translated into a clinically relevant benefit with significantly fewer major adverse events for DEB versus uncoated balloons up to 12 months (3 [7.1%] versus 15 [34.9%], P<0.01) as well as target lesion revascularizations (3 [7.1%] versus 12 [27.9%], P=0.02). Conclusions-Use of IN.PACT Pacific DEB is associated with significant reductions in late lumen loss and restenoses at 6 months, and reinterventions after femoro-popliteal percutaneous transluminal angioplasty up to 1 year of follow-up. © 2012 American Heart Association, Inc.
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Exclude
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DE3 - Incorrect Device
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: Evidence from the randomized PACIFIER trial ###Abstract: Background-Peripheral percutaneous transluminal angioplasty is fraught with a substantial risk of restenosis and reintervention. A drug-eluting balloon (DEB) based on a novel coating was compared with uncoated balloons in patients undergoing femoro-popliteal percutaneous transluminal angioplasty. Methods and Results-Patients with symptomatic femoro-popliteal atherosclerotic disease undergoing percutaneous transluminal angioplasty were randomized to paclitaxel-coated IN.PACT Pacific or uncoated Pacific balloons. The primary end point was late lumen loss at 6 months assessed by blinded angiographic corelab quantitative analyses. Secondary end points were binary restenosis and Rutherford class change at 6 months, and target lesion revascularization plus major adverse clinical events (major adverse events=death, target limb amputation, or target lesion revascularization) at 6 and 12 months. Eighty-five patients (91 cases=interventional procedures) were randomized in 3 hospitals (44 to DEB and 47 to uncoated balloons). Average lesion length was 7.0±5.3 and 6.6±5.5cm for DEB and control arm, respectively. Procedural success was obtained in all cases. Six-month quantitative angiography showed that DEB were associated with significantly lower late lumen loss (-0.01mm [95% CI, -0.29; 0.26] versus 0.65mm [0.37; 0.93], P=0.001) and fewer binary restenoses (3 [8.6%] versus 11 [32.4%], P=0.01). This translated into a clinically relevant benefit with significantly fewer major adverse events for DEB versus uncoated balloons up to 12 months (3 [7.1%] versus 15 [34.9%], P<0.01) as well as target lesion revascularizations (3 [7.1%] versus 12 [27.9%], P=0.02). Conclusions-Use of IN.PACT Pacific DEB is associated with significant reductions in late lumen loss and restenoses at 6 months, and reinterventions after femoro-popliteal percutaneous transluminal angioplasty up to 1 year of follow-up. © 2012 American Heart Association, Inc. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: Evidence from the randomized PACIFIER trial ###Abstract: Background-Peripheral percutaneous transluminal angioplasty is fraught with a substantial risk of restenosis and reintervention. A drug-eluting balloon (DEB) based on a novel coating was compared with uncoated balloons in patients undergoing femoro-popliteal percutaneous transluminal angioplasty. Methods and Results-Patients with symptomatic femoro-popliteal atherosclerotic disease undergoing percutaneous transluminal angioplasty were randomized to paclitaxel-coated IN.PACT Pacific or uncoated Pacific balloons. The primary end point was late lumen loss at 6 months assessed by blinded angiographic corelab quantitative analyses. Secondary end points were binary restenosis and Rutherford class change at 6 months, and target lesion revascularization plus major adverse clinical events (major adverse events=death, target limb amputation, or target lesion revascularization) at 6 and 12 months. Eighty-five patients (91 cases=interventional procedures) were randomized in 3 hospitals (44 to DEB and 47 to uncoated balloons). Average lesion length was 7.0±5.3 and 6.6±5.5cm for DEB and control arm, respectively. Procedural success was obtained in all cases. Six-month quantitative angiography showed that DEB were associated with significantly lower late lumen loss (-0.01mm [95% CI, -0.29; 0.26] versus 0.65mm [0.37; 0.93], P=0.001) and fewer binary restenoses (3 [8.6%] versus 11 [32.4%], P=0.01). This translated into a clinically relevant benefit with significantly fewer major adverse events for DEB versus uncoated balloons up to 12 months (3 [7.1%] versus 15 [34.9%], P<0.01) as well as target lesion revascularizations (3 [7.1%] versus 12 [27.9%], P=0.02). Conclusions-Use of IN.PACT Pacific DEB is associated with significant reductions in late lumen loss and restenoses at 6 months, and reinterventions after femoro-popliteal percutaneous transluminal angioplasty up to 1 year of follow-up. © 2012 American Heart Association, Inc. [/INST] Exclude </s>
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Werk 2012b
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Q&A with Dr. Michael Werk, of Martin Luther Hospital, about femoropopliteal lesions and the PACIFIER trial
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DE12 - Wrong Article Type
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Q&A with Dr. Michael Werk, of Martin Luther Hospital, about femoropopliteal lesions and the PACIFIER trial ###Abstract: None [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Q&A with Dr. Michael Werk, of Martin Luther Hospital, about femoropopliteal lesions and the PACIFIER trial ###Abstract: None [/INST] Exclude </s>
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Werner 2013
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Bifurcation stenting after failed angioplasty of infrapopliteal arteries in critical limb ischemia: Techniques and short-term follow-up
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Objectives To report on the efficacy of drug eluting stents (DES) in below the knee lesions involving arterial bifurcations after failed angioplasty. Background DES have become a mainstay in the treatment of below the knee lesions. However, little is known about the efficacy of DES in infapopliteal lesions involving the arterial bifurcations. This is the first report on the endovascular treatment of below-the knee bifurcations. Methods 11 patients with critical lower limb ischemia and complex infrapopliteal atherosclerotic disease underwent provisional DES placement in infrapopliteal bifurcation lesions. Clinical and angiographic follow-up data were prospectively collected in all patients. Results Technical success was achieved in all cases. After 6 months, the two vessel primary patency (2VPP) rate was 54.5% and the 1VPP rate was 81.8%. Between baseline and the follow-up, mean ankle-brachial index increased from 0.31 ± 0.10 to 0.68 ± 0.16, and mean Rutherford-Becker class decreased from 4.73 ± 0.20 to 3.00 ± 1.41 (P < 0.001 for both comparisons). Conclusions Bifurcation stenting techniques, that are described for the coronary arteries can be also performed in the infrapopliteal arteries. However, early reocclusion was frequent in this case series, when stenting was performed in a bail-out setting. If balloon angioplasty alone leads to no sufficient results in bifurcation lesions, a single stent strategy could also be considered. Copyright © 2013 Wiley Periodicals, Inc.
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Exclude
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DE4 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Bifurcation stenting after failed angioplasty of infrapopliteal arteries in critical limb ischemia: Techniques and short-term follow-up ###Abstract: Objectives To report on the efficacy of drug eluting stents (DES) in below the knee lesions involving arterial bifurcations after failed angioplasty. Background DES have become a mainstay in the treatment of below the knee lesions. However, little is known about the efficacy of DES in infapopliteal lesions involving the arterial bifurcations. This is the first report on the endovascular treatment of below-the knee bifurcations. Methods 11 patients with critical lower limb ischemia and complex infrapopliteal atherosclerotic disease underwent provisional DES placement in infrapopliteal bifurcation lesions. Clinical and angiographic follow-up data were prospectively collected in all patients. Results Technical success was achieved in all cases. After 6 months, the two vessel primary patency (2VPP) rate was 54.5% and the 1VPP rate was 81.8%. Between baseline and the follow-up, mean ankle-brachial index increased from 0.31 ± 0.10 to 0.68 ± 0.16, and mean Rutherford-Becker class decreased from 4.73 ± 0.20 to 3.00 ± 1.41 (P < 0.001 for both comparisons). Conclusions Bifurcation stenting techniques, that are described for the coronary arteries can be also performed in the infrapopliteal arteries. However, early reocclusion was frequent in this case series, when stenting was performed in a bail-out setting. If balloon angioplasty alone leads to no sufficient results in bifurcation lesions, a single stent strategy could also be considered. Copyright © 2013 Wiley Periodicals, Inc. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Bifurcation stenting after failed angioplasty of infrapopliteal arteries in critical limb ischemia: Techniques and short-term follow-up ###Abstract: Objectives To report on the efficacy of drug eluting stents (DES) in below the knee lesions involving arterial bifurcations after failed angioplasty. Background DES have become a mainstay in the treatment of below the knee lesions. However, little is known about the efficacy of DES in infapopliteal lesions involving the arterial bifurcations. This is the first report on the endovascular treatment of below-the knee bifurcations. Methods 11 patients with critical lower limb ischemia and complex infrapopliteal atherosclerotic disease underwent provisional DES placement in infrapopliteal bifurcation lesions. Clinical and angiographic follow-up data were prospectively collected in all patients. Results Technical success was achieved in all cases. After 6 months, the two vessel primary patency (2VPP) rate was 54.5% and the 1VPP rate was 81.8%. Between baseline and the follow-up, mean ankle-brachial index increased from 0.31 ± 0.10 to 0.68 ± 0.16, and mean Rutherford-Becker class decreased from 4.73 ± 0.20 to 3.00 ± 1.41 (P < 0.001 for both comparisons). Conclusions Bifurcation stenting techniques, that are described for the coronary arteries can be also performed in the infrapopliteal arteries. However, early reocclusion was frequent in this case series, when stenting was performed in a bail-out setting. If balloon angioplasty alone leads to no sufficient results in bifurcation lesions, a single stent strategy could also be considered. Copyright © 2013 Wiley Periodicals, Inc. [/INST] Exclude </s>
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Wöhrle 2012
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Drug-coated balloons for coronary and peripheral interventional procedures
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Paclitaxel-coated balloon (PCB) angioplasty reduces neointimal proliferation, restenosis, and clinical need for target lesion revascularization (TLR). PCB was superior for coronary restenosis in bare-metal and drugeluting stents compared with uncoated balloon angioplasty and was noninferior compared with paclitaxel-eluting stents. PCB angioplasty should be considered for treatment of coronary in-stent restenosis. For de novo lesions, PCB plus endothelial progenitor cell capturing stents reduced restenosis and TLR in early reports. Among patients with de novo lesions and diabetes, the combination of PCB plus baremetal stent revealed similar results in lesions compared with paclitaxel-eluting stents. The early results for PCB in small vessels are also very encouraging. Dual antiplatelet therapy duration may be shorter with PCB angioplasty compared with drug-eluting stents. Nevertheless, the risk for thrombotic vessel occlusion is minimized. Considering peripheral arterial disease, PCB angioplasty for femoropopliteal lesions was superior to uncoated balloon angioplasty. Registries indicate PCB to also be effective in lesions below the knee. Since there is no certain class effect, efficacy and safety have to be demonstrated for different types of PCB for coronary and peripheral interventions. © 2012 Springer Science+Business Media, LLC.
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Exclude
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DE4 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloons for coronary and peripheral interventional procedures ###Abstract: Paclitaxel-coated balloon (PCB) angioplasty reduces neointimal proliferation, restenosis, and clinical need for target lesion revascularization (TLR). PCB was superior for coronary restenosis in bare-metal and drugeluting stents compared with uncoated balloon angioplasty and was noninferior compared with paclitaxel-eluting stents. PCB angioplasty should be considered for treatment of coronary in-stent restenosis. For de novo lesions, PCB plus endothelial progenitor cell capturing stents reduced restenosis and TLR in early reports. Among patients with de novo lesions and diabetes, the combination of PCB plus baremetal stent revealed similar results in lesions compared with paclitaxel-eluting stents. The early results for PCB in small vessels are also very encouraging. Dual antiplatelet therapy duration may be shorter with PCB angioplasty compared with drug-eluting stents. Nevertheless, the risk for thrombotic vessel occlusion is minimized. Considering peripheral arterial disease, PCB angioplasty for femoropopliteal lesions was superior to uncoated balloon angioplasty. Registries indicate PCB to also be effective in lesions below the knee. Since there is no certain class effect, efficacy and safety have to be demonstrated for different types of PCB for coronary and peripheral interventions. © 2012 Springer Science+Business Media, LLC. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloons for coronary and peripheral interventional procedures ###Abstract: Paclitaxel-coated balloon (PCB) angioplasty reduces neointimal proliferation, restenosis, and clinical need for target lesion revascularization (TLR). PCB was superior for coronary restenosis in bare-metal and drugeluting stents compared with uncoated balloon angioplasty and was noninferior compared with paclitaxel-eluting stents. PCB angioplasty should be considered for treatment of coronary in-stent restenosis. For de novo lesions, PCB plus endothelial progenitor cell capturing stents reduced restenosis and TLR in early reports. Among patients with de novo lesions and diabetes, the combination of PCB plus baremetal stent revealed similar results in lesions compared with paclitaxel-eluting stents. The early results for PCB in small vessels are also very encouraging. Dual antiplatelet therapy duration may be shorter with PCB angioplasty compared with drug-eluting stents. Nevertheless, the risk for thrombotic vessel occlusion is minimized. Considering peripheral arterial disease, PCB angioplasty for femoropopliteal lesions was superior to uncoated balloon angioplasty. Registries indicate PCB to also be effective in lesions below the knee. Since there is no certain class effect, efficacy and safety have to be demonstrated for different types of PCB for coronary and peripheral interventions. © 2012 Springer Science+Business Media, LLC. [/INST] Exclude </s>
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Yiu 2015
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The roles of drug-eluting technology and atherectomy in infrapopliteal occlusive disease
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Chronic limb threatening ischemia (CLI) is often associated with occlusive disease of the infrapopliteal arteries. Percutaneous balloon angioplasty has been a standard treatment modality for infrainguinal arterial occlusive disease, but its use is limited by its relatively high restenosis rate and the frequent need of re-intervention, especially in below-the-knee (BTK) arteries. In the past decade, ongoing technology innovations, such as drug-coated balloon and drug-eluting stents have shown promising results in peripheral arterial disease. Atherectomy, a plaque debulking technology capable of disobliterating heavily calcified vessels, has also been advocated for BTK disease. However there is little in the way of high-quality comparative data to discern the relative efficacy of these interventional approaches versus each other, or versus open surgery. This review provides a current summary of evidence for these technologies in the setting of CLI and BTK occlusive disease.
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Exclude
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DE12 - Wrong Article Type
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: The roles of drug-eluting technology and atherectomy in infrapopliteal occlusive disease ###Abstract: Chronic limb threatening ischemia (CLI) is often associated with occlusive disease of the infrapopliteal arteries. Percutaneous balloon angioplasty has been a standard treatment modality for infrainguinal arterial occlusive disease, but its use is limited by its relatively high restenosis rate and the frequent need of re-intervention, especially in below-the-knee (BTK) arteries. In the past decade, ongoing technology innovations, such as drug-coated balloon and drug-eluting stents have shown promising results in peripheral arterial disease. Atherectomy, a plaque debulking technology capable of disobliterating heavily calcified vessels, has also been advocated for BTK disease. However there is little in the way of high-quality comparative data to discern the relative efficacy of these interventional approaches versus each other, or versus open surgery. This review provides a current summary of evidence for these technologies in the setting of CLI and BTK occlusive disease. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: The roles of drug-eluting technology and atherectomy in infrapopliteal occlusive disease ###Abstract: Chronic limb threatening ischemia (CLI) is often associated with occlusive disease of the infrapopliteal arteries. Percutaneous balloon angioplasty has been a standard treatment modality for infrainguinal arterial occlusive disease, but its use is limited by its relatively high restenosis rate and the frequent need of re-intervention, especially in below-the-knee (BTK) arteries. In the past decade, ongoing technology innovations, such as drug-coated balloon and drug-eluting stents have shown promising results in peripheral arterial disease. Atherectomy, a plaque debulking technology capable of disobliterating heavily calcified vessels, has also been advocated for BTK disease. However there is little in the way of high-quality comparative data to discern the relative efficacy of these interventional approaches versus each other, or versus open surgery. This review provides a current summary of evidence for these technologies in the setting of CLI and BTK occlusive disease. [/INST] Exclude </s>
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Young 2013
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PTCA with drug-coated balloons is associated with immediate decrease of coronary flow reserve
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Introduction Drug-coated balloons (DCB) are being increasingly used in interventional cardiology. The effect of DCB on acute changes of coronary flow reserve (CFR) has never been reported. Methods Patients with in-stent restenosis or with contraindication for use of clopidogrel were included in this study. The FloWire was used to assess CFR before and immediately after conventional balloon angioplasty and after the use of In.Pact, a paclitaxel-coated balloon. In a sub-selection of patients, CFR was measured immediately and then 2, 5, and 10 min post-DCB. Results Thirty patients (18 males, 60%) with a total of 32 lesions were studied. Comparison of CFR pre- and post-conventional balloon angioplasty was not statistically significant (P = 0.95). CFR dropped significantly after the use of In.Pact (n = 32, 1.59 ± 0.49 vs. 1.22 ± 0.28, P < 0.0001) and showed a statistically significant improvement over 10 min in a subset of patients (n = 6, P = 0.01). Implantation of a coronary stent after the use of In.Pact rapidly improved CFR (n = 10, P = 0.0004). Conclusions We describe a novel phenomenon of acute decrease in CFR after the use of DCB. This phenomenon is temporary and spontaneously improves after approximately 10 min. The exact pathophysiological mechanism remains unclear and further studies are warranted to study the long-term effects of acute CFR drop after use of DCB. © 2011 Wiley Periodicals, Inc.
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Include
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Review Full Text
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: PTCA with drug-coated balloons is associated with immediate decrease of coronary flow reserve ###Abstract: Introduction Drug-coated balloons (DCB) are being increasingly used in interventional cardiology. The effect of DCB on acute changes of coronary flow reserve (CFR) has never been reported. Methods Patients with in-stent restenosis or with contraindication for use of clopidogrel were included in this study. The FloWire was used to assess CFR before and immediately after conventional balloon angioplasty and after the use of In.Pact, a paclitaxel-coated balloon. In a sub-selection of patients, CFR was measured immediately and then 2, 5, and 10 min post-DCB. Results Thirty patients (18 males, 60%) with a total of 32 lesions were studied. Comparison of CFR pre- and post-conventional balloon angioplasty was not statistically significant (P = 0.95). CFR dropped significantly after the use of In.Pact (n = 32, 1.59 ± 0.49 vs. 1.22 ± 0.28, P < 0.0001) and showed a statistically significant improvement over 10 min in a subset of patients (n = 6, P = 0.01). Implantation of a coronary stent after the use of In.Pact rapidly improved CFR (n = 10, P = 0.0004). Conclusions We describe a novel phenomenon of acute decrease in CFR after the use of DCB. This phenomenon is temporary and spontaneously improves after approximately 10 min. The exact pathophysiological mechanism remains unclear and further studies are warranted to study the long-term effects of acute CFR drop after use of DCB. © 2011 Wiley Periodicals, Inc. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: PTCA with drug-coated balloons is associated with immediate decrease of coronary flow reserve ###Abstract: Introduction Drug-coated balloons (DCB) are being increasingly used in interventional cardiology. The effect of DCB on acute changes of coronary flow reserve (CFR) has never been reported. Methods Patients with in-stent restenosis or with contraindication for use of clopidogrel were included in this study. The FloWire was used to assess CFR before and immediately after conventional balloon angioplasty and after the use of In.Pact, a paclitaxel-coated balloon. In a sub-selection of patients, CFR was measured immediately and then 2, 5, and 10 min post-DCB. Results Thirty patients (18 males, 60%) with a total of 32 lesions were studied. Comparison of CFR pre- and post-conventional balloon angioplasty was not statistically significant (P = 0.95). CFR dropped significantly after the use of In.Pact (n = 32, 1.59 ± 0.49 vs. 1.22 ± 0.28, P < 0.0001) and showed a statistically significant improvement over 10 min in a subset of patients (n = 6, P = 0.01). Implantation of a coronary stent after the use of In.Pact rapidly improved CFR (n = 10, P = 0.0004). Conclusions We describe a novel phenomenon of acute decrease in CFR after the use of DCB. This phenomenon is temporary and spontaneously improves after approximately 10 min. The exact pathophysiological mechanism remains unclear and further studies are warranted to study the long-term effects of acute CFR drop after use of DCB. © 2011 Wiley Periodicals, Inc. [/INST] Include </s>
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Zeller 2011a
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Drug-coated balloons in the lower limb
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Even if recently the first positive results were presented for a paclitaxel releasing drug eluting stent there are still concerns about stent implantation in the femoro-popliteal artery. This makes any stentless technology attractive that achieves at least as good acute and longer term results in this vessel area. Three randomized studies investigating the value of short time paclitaxel release using a drug coated balloon gave promising results with significantly improved patency rates compared to plain balloon angioplasty in femoro-popliteal lesions and at least as good patency results as for the majority of bare metal nitinol stents (THUNDER, FEMPAC, LEVANT 1). Below-the-knee this promising concept is still under evaluation (PICCOLO study) whereas the first positive results for drug eluting stents in shorter lesions had been recently presented (YUKON BTK, DESTINY). This article gives an overview upon already published and presented data and still ongoing trials on drug releasing balloons in the peripheral arteries.
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Exclude
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DE4 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloons in the lower limb ###Abstract: Even if recently the first positive results were presented for a paclitaxel releasing drug eluting stent there are still concerns about stent implantation in the femoro-popliteal artery. This makes any stentless technology attractive that achieves at least as good acute and longer term results in this vessel area. Three randomized studies investigating the value of short time paclitaxel release using a drug coated balloon gave promising results with significantly improved patency rates compared to plain balloon angioplasty in femoro-popliteal lesions and at least as good patency results as for the majority of bare metal nitinol stents (THUNDER, FEMPAC, LEVANT 1). Below-the-knee this promising concept is still under evaluation (PICCOLO study) whereas the first positive results for drug eluting stents in shorter lesions had been recently presented (YUKON BTK, DESTINY). This article gives an overview upon already published and presented data and still ongoing trials on drug releasing balloons in the peripheral arteries. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloons in the lower limb ###Abstract: Even if recently the first positive results were presented for a paclitaxel releasing drug eluting stent there are still concerns about stent implantation in the femoro-popliteal artery. This makes any stentless technology attractive that achieves at least as good acute and longer term results in this vessel area. Three randomized studies investigating the value of short time paclitaxel release using a drug coated balloon gave promising results with significantly improved patency rates compared to plain balloon angioplasty in femoro-popliteal lesions and at least as good patency results as for the majority of bare metal nitinol stents (THUNDER, FEMPAC, LEVANT 1). Below-the-knee this promising concept is still under evaluation (PICCOLO study) whereas the first positive results for drug eluting stents in shorter lesions had been recently presented (YUKON BTK, DESTINY). This article gives an overview upon already published and presented data and still ongoing trials on drug releasing balloons in the peripheral arteries. [/INST] Exclude </s>
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Zeller 2011b
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Renal artery intervention - Endovascular techniques
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Significant renal artery stenosis (RAS) may result in deterioration of arterial hypertension and/or renal insufficiency and may contribute to cardiovascular diseases such as diastolic and systolic heart failure. Percutaneous transluminal angioplasty (PTA) is the established therapy for RAS of fibromuscular disease origin. The role of cutting balloon angioplasty in this indication still needs to be investigated. In atherosclerotic RAS, stenting has shown superior acute and long-term technical outcomes compared to PTA. Technical improvements such as dedicated guiding catheters, the downsizing of devices including wires, balloon catheters and stents, made the intervention more successful and safer. Numerous single-center studies have reported the beneficial effects of percutaneous revascularization of RAS of different etiologies. Even if the recent randomized STAR and ASTRAL trials did not show any benefit of RAS revascularization over medical therapy, there is nonetheless evidence that stenting of hemodynamically relevant atherosclerotic RAS has an impact on blood pressure control, renal function and left ventricular hypertrophy. This article introduces interventional treatment techniques step-by-step.
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Exclude
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DE4 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Renal artery intervention - Endovascular techniques ###Abstract: Significant renal artery stenosis (RAS) may result in deterioration of arterial hypertension and/or renal insufficiency and may contribute to cardiovascular diseases such as diastolic and systolic heart failure. Percutaneous transluminal angioplasty (PTA) is the established therapy for RAS of fibromuscular disease origin. The role of cutting balloon angioplasty in this indication still needs to be investigated. In atherosclerotic RAS, stenting has shown superior acute and long-term technical outcomes compared to PTA. Technical improvements such as dedicated guiding catheters, the downsizing of devices including wires, balloon catheters and stents, made the intervention more successful and safer. Numerous single-center studies have reported the beneficial effects of percutaneous revascularization of RAS of different etiologies. Even if the recent randomized STAR and ASTRAL trials did not show any benefit of RAS revascularization over medical therapy, there is nonetheless evidence that stenting of hemodynamically relevant atherosclerotic RAS has an impact on blood pressure control, renal function and left ventricular hypertrophy. This article introduces interventional treatment techniques step-by-step. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Renal artery intervention - Endovascular techniques ###Abstract: Significant renal artery stenosis (RAS) may result in deterioration of arterial hypertension and/or renal insufficiency and may contribute to cardiovascular diseases such as diastolic and systolic heart failure. Percutaneous transluminal angioplasty (PTA) is the established therapy for RAS of fibromuscular disease origin. The role of cutting balloon angioplasty in this indication still needs to be investigated. In atherosclerotic RAS, stenting has shown superior acute and long-term technical outcomes compared to PTA. Technical improvements such as dedicated guiding catheters, the downsizing of devices including wires, balloon catheters and stents, made the intervention more successful and safer. Numerous single-center studies have reported the beneficial effects of percutaneous revascularization of RAS of different etiologies. Even if the recent randomized STAR and ASTRAL trials did not show any benefit of RAS revascularization over medical therapy, there is nonetheless evidence that stenting of hemodynamically relevant atherosclerotic RAS has an impact on blood pressure control, renal function and left ventricular hypertrophy. This article introduces interventional treatment techniques step-by-step. [/INST] Exclude </s>
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Zeller 2014a
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IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: Rationale and protocol for an ongoing randomized controlled trial
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Background: The effectiveness and durability of endovascular revascularization therapies for chronic critical limb ischemia (CLI) are challenged by the extensive burden of infrapopliteal arterial disease and lesion-related characteristics (e.g., severe calcification, chronic total occlusions), which frequently result in poor clinical outcomes. While infrapopliteal vessel patency directly affects pain relief and wound healing, sustained patency and extravascular care both contribute to the ultimate " patient-centric" outcomes of functional limb preservation, mobility and quality of life (QoL).Methods/Design: IN.PACT DEEP is a 2:1 randomized controlled trial designed to assess the efficacy and safety of infrapopliteal arterial revascularization between the IN.PACT Amphirion™ paclitaxel drug-eluting balloon (IA-DEB) and standard balloon angioplasty (PTA) in patients with Rutherford Class 4-5-6 CLI.Discussion: This multicenter trial has enrolled 358 patients at 13 European centers with independent angiographic core lab adjudication of the primary efficacy endpoint of target lesion late luminal loss (LLL) and clinically driven target lesion revascularization (TLR) in major amputation-free surviving patients through 12-months. An independent wound core lab will evaluate all ischemic wounds to assess the extent of healing and time to healing at 1, 6, and 12 months. A QoL questionnaire including a pain scale will assess changes from baseline scores through 12 months. A Clinical Events Committee and Data Safety Monitoring Board will adjudicate the composite primary safety endpoints of all-cause death, major amputation, and clinically driven TLR at 6 months and other trial endpoints and supervise patient safety throughout the study. All patients will be followed for 5 years. A literature review is presented of the current status of endovascular treatment of CLI with drug-eluting balloon and standard PTA. The rationale and design of the IN.PACT DEEP Trial are discussed. IN.PACT DEEP is a milestone, prospective, randomized, robust, independent core lab-adjudicated CLI trial that will evaluate the role of a new infrapopliteal revascularization technology, the IA-DEB, compared to PTA. It will assess the overall impact on infrapopliteal artery patency, limb salvage, wound healing, pain control, QoL, and patient mobility. The 1-year results of the adjudicated co-primary and secondary endpoints will be available in 2014.Trial registration: NCT00941733. © 2014 Zeller et al.; licensee BioMed Central Ltd.
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Exclude
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DE3 - Incorrect Device
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: Rationale and protocol for an ongoing randomized controlled trial ###Abstract: Background: The effectiveness and durability of endovascular revascularization therapies for chronic critical limb ischemia (CLI) are challenged by the extensive burden of infrapopliteal arterial disease and lesion-related characteristics (e.g., severe calcification, chronic total occlusions), which frequently result in poor clinical outcomes. While infrapopliteal vessel patency directly affects pain relief and wound healing, sustained patency and extravascular care both contribute to the ultimate " patient-centric" outcomes of functional limb preservation, mobility and quality of life (QoL).Methods/Design: IN.PACT DEEP is a 2:1 randomized controlled trial designed to assess the efficacy and safety of infrapopliteal arterial revascularization between the IN.PACT Amphirion™ paclitaxel drug-eluting balloon (IA-DEB) and standard balloon angioplasty (PTA) in patients with Rutherford Class 4-5-6 CLI.Discussion: This multicenter trial has enrolled 358 patients at 13 European centers with independent angiographic core lab adjudication of the primary efficacy endpoint of target lesion late luminal loss (LLL) and clinically driven target lesion revascularization (TLR) in major amputation-free surviving patients through 12-months. An independent wound core lab will evaluate all ischemic wounds to assess the extent of healing and time to healing at 1, 6, and 12 months. A QoL questionnaire including a pain scale will assess changes from baseline scores through 12 months. A Clinical Events Committee and Data Safety Monitoring Board will adjudicate the composite primary safety endpoints of all-cause death, major amputation, and clinically driven TLR at 6 months and other trial endpoints and supervise patient safety throughout the study. All patients will be followed for 5 years. A literature review is presented of the current status of endovascular treatment of CLI with drug-eluting balloon and standard PTA. The rationale and design of the IN.PACT DEEP Trial are discussed. IN.PACT DEEP is a milestone, prospective, randomized, robust, independent core lab-adjudicated CLI trial that will evaluate the role of a new infrapopliteal revascularization technology, the IA-DEB, compared to PTA. It will assess the overall impact on infrapopliteal artery patency, limb salvage, wound healing, pain control, QoL, and patient mobility. The 1-year results of the adjudicated co-primary and secondary endpoints will be available in 2014.Trial registration: NCT00941733. © 2014 Zeller et al.; licensee BioMed Central Ltd. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: Rationale and protocol for an ongoing randomized controlled trial ###Abstract: Background: The effectiveness and durability of endovascular revascularization therapies for chronic critical limb ischemia (CLI) are challenged by the extensive burden of infrapopliteal arterial disease and lesion-related characteristics (e.g., severe calcification, chronic total occlusions), which frequently result in poor clinical outcomes. While infrapopliteal vessel patency directly affects pain relief and wound healing, sustained patency and extravascular care both contribute to the ultimate " patient-centric" outcomes of functional limb preservation, mobility and quality of life (QoL).Methods/Design: IN.PACT DEEP is a 2:1 randomized controlled trial designed to assess the efficacy and safety of infrapopliteal arterial revascularization between the IN.PACT Amphirion™ paclitaxel drug-eluting balloon (IA-DEB) and standard balloon angioplasty (PTA) in patients with Rutherford Class 4-5-6 CLI.Discussion: This multicenter trial has enrolled 358 patients at 13 European centers with independent angiographic core lab adjudication of the primary efficacy endpoint of target lesion late luminal loss (LLL) and clinically driven target lesion revascularization (TLR) in major amputation-free surviving patients through 12-months. An independent wound core lab will evaluate all ischemic wounds to assess the extent of healing and time to healing at 1, 6, and 12 months. A QoL questionnaire including a pain scale will assess changes from baseline scores through 12 months. A Clinical Events Committee and Data Safety Monitoring Board will adjudicate the composite primary safety endpoints of all-cause death, major amputation, and clinically driven TLR at 6 months and other trial endpoints and supervise patient safety throughout the study. All patients will be followed for 5 years. A literature review is presented of the current status of endovascular treatment of CLI with drug-eluting balloon and standard PTA. The rationale and design of the IN.PACT DEEP Trial are discussed. IN.PACT DEEP is a milestone, prospective, randomized, robust, independent core lab-adjudicated CLI trial that will evaluate the role of a new infrapopliteal revascularization technology, the IA-DEB, compared to PTA. It will assess the overall impact on infrapopliteal artery patency, limb salvage, wound healing, pain control, QoL, and patient mobility. The 1-year results of the adjudicated co-primary and secondary endpoints will be available in 2014.Trial registration: NCT00941733. © 2014 Zeller et al.; licensee BioMed Central Ltd. [/INST] Exclude </s>
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Zeller 2014b
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Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-Month results from the IN.PACT deep randomized trial
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Background Drug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation.Objectives The goal of this clinical trial was to assess the efficacy and safety of IN.PACT Amphirion drug-eluting balloons (IA-DEB) compared to PTA for infrapopliteal arterial revascularization in patients with critical limb ischemia (CLI).Methods Within a prospective, multicenter, randomized, controlled trial with independent clinical event adjudication and angiographic and wound core laboratories 358 CLI patients were randomized 2:1 to IA-DEB or PTA. The 2 coprimary efficacy endpoints through 12 months were clinically driven target lesion revascularization (CD-TLR) and late lumen loss (LLL). The primary safety endpoint through 6 months was a composite of all-cause mortality, major amputation, and CD-TLR.Results Clinical characteristics were similar between the 2 groups. Significant baseline differences between the IA-DEB and PTA arms included mean lesion length (10.2 cm vs. 12.9 cm; p = 0.002), impaired inflow (40.7% vs. 28.8%; p = 0.035), and previous target limb revascularization (32.2% vs. 21.8%; p = 0.047). Primary efficacy results of IA-DEB versus PTA were CD-TLR of 9.2% versus 13.1% (p = 0.291) and LLL of 0.61 ± 0.78 mm versus 0.62 ± 0.78 mm (p = 0.950). Primary safety endpoints were 17.7% versus 15.8% (p = 0.021) and met the noninferiority hypothesis. A safety signal driven by major amputations through 12 months was observed in the IA-DEB arm versus the PTA arm (8.8% vs. 3.6%; p = 0.080).Conclusions In patients with CLI, IA-DEB had comparable efficacy to PTA. While primary safety was met, there was a trend towards an increased major amputation rate through 12 months compared to PTA. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733).
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Exclude
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DE3 - Incorrect Device
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-Month results from the IN.PACT deep randomized trial ###Abstract: Background Drug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation.Objectives The goal of this clinical trial was to assess the efficacy and safety of IN.PACT Amphirion drug-eluting balloons (IA-DEB) compared to PTA for infrapopliteal arterial revascularization in patients with critical limb ischemia (CLI).Methods Within a prospective, multicenter, randomized, controlled trial with independent clinical event adjudication and angiographic and wound core laboratories 358 CLI patients were randomized 2:1 to IA-DEB or PTA. The 2 coprimary efficacy endpoints through 12 months were clinically driven target lesion revascularization (CD-TLR) and late lumen loss (LLL). The primary safety endpoint through 6 months was a composite of all-cause mortality, major amputation, and CD-TLR.Results Clinical characteristics were similar between the 2 groups. Significant baseline differences between the IA-DEB and PTA arms included mean lesion length (10.2 cm vs. 12.9 cm; p = 0.002), impaired inflow (40.7% vs. 28.8%; p = 0.035), and previous target limb revascularization (32.2% vs. 21.8%; p = 0.047). Primary efficacy results of IA-DEB versus PTA were CD-TLR of 9.2% versus 13.1% (p = 0.291) and LLL of 0.61 ± 0.78 mm versus 0.62 ± 0.78 mm (p = 0.950). Primary safety endpoints were 17.7% versus 15.8% (p = 0.021) and met the noninferiority hypothesis. A safety signal driven by major amputations through 12 months was observed in the IA-DEB arm versus the PTA arm (8.8% vs. 3.6%; p = 0.080).Conclusions In patients with CLI, IA-DEB had comparable efficacy to PTA. While primary safety was met, there was a trend towards an increased major amputation rate through 12 months compared to PTA. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733). [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-Month results from the IN.PACT deep randomized trial ###Abstract: Background Drug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation.Objectives The goal of this clinical trial was to assess the efficacy and safety of IN.PACT Amphirion drug-eluting balloons (IA-DEB) compared to PTA for infrapopliteal arterial revascularization in patients with critical limb ischemia (CLI).Methods Within a prospective, multicenter, randomized, controlled trial with independent clinical event adjudication and angiographic and wound core laboratories 358 CLI patients were randomized 2:1 to IA-DEB or PTA. The 2 coprimary efficacy endpoints through 12 months were clinically driven target lesion revascularization (CD-TLR) and late lumen loss (LLL). The primary safety endpoint through 6 months was a composite of all-cause mortality, major amputation, and CD-TLR.Results Clinical characteristics were similar between the 2 groups. Significant baseline differences between the IA-DEB and PTA arms included mean lesion length (10.2 cm vs. 12.9 cm; p = 0.002), impaired inflow (40.7% vs. 28.8%; p = 0.035), and previous target limb revascularization (32.2% vs. 21.8%; p = 0.047). Primary efficacy results of IA-DEB versus PTA were CD-TLR of 9.2% versus 13.1% (p = 0.291) and LLL of 0.61 ± 0.78 mm versus 0.62 ± 0.78 mm (p = 0.950). Primary safety endpoints were 17.7% versus 15.8% (p = 0.021) and met the noninferiority hypothesis. A safety signal driven by major amputations through 12 months was observed in the IA-DEB arm versus the PTA arm (8.8% vs. 3.6%; p = 0.080).Conclusions In patients with CLI, IA-DEB had comparable efficacy to PTA. While primary safety was met, there was a trend towards an increased major amputation rate through 12 months compared to PTA. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733). [/INST] Exclude </s>
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Zeller 2015
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Drug-Coated Balloons: How Should We Incorporate Into Our Practice in Treating Superficial Femoral Artery Lesions?
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Drug-coated balloons (DCBs) provide a novel method to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system. Following the first positive pilot studies, two large pivotal trials have confirmed superiority of DCBs over plain old balloon angioplasty (POBA) in the treatment of TASC II A and B femoro-popliteal lesions. Even for more complex femoro-popliteal lesions such as long lesions and in-stent restenosis, single-center studies and small randomized studies have shown promising mid-term technical and clinical results. This review article summarizes the current knowledge about DCBs in femoro-popliteal interventions, supplements published guidelines with evidence-based recommendations, and discusses still unresolved needs.
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DE12 - Wrong Article Type
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloons: How Should We Incorporate Into Our Practice in Treating Superficial Femoral Artery Lesions? ###Abstract: Drug-coated balloons (DCBs) provide a novel method to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system. Following the first positive pilot studies, two large pivotal trials have confirmed superiority of DCBs over plain old balloon angioplasty (POBA) in the treatment of TASC II A and B femoro-popliteal lesions. Even for more complex femoro-popliteal lesions such as long lesions and in-stent restenosis, single-center studies and small randomized studies have shown promising mid-term technical and clinical results. This review article summarizes the current knowledge about DCBs in femoro-popliteal interventions, supplements published guidelines with evidence-based recommendations, and discusses still unresolved needs. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloons: How Should We Incorporate Into Our Practice in Treating Superficial Femoral Artery Lesions? ###Abstract: Drug-coated balloons (DCBs) provide a novel method to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system. Following the first positive pilot studies, two large pivotal trials have confirmed superiority of DCBs over plain old balloon angioplasty (POBA) in the treatment of TASC II A and B femoro-popliteal lesions. Even for more complex femoro-popliteal lesions such as long lesions and in-stent restenosis, single-center studies and small randomized studies have shown promising mid-term technical and clinical results. This review article summarizes the current knowledge about DCBs in femoro-popliteal interventions, supplements published guidelines with evidence-based recommendations, and discusses still unresolved needs. [/INST] Exclude </s>
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