Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the safety and efficacy of the paclitaxel releasing balloon in patients with in-stent restenosis in a coronary artery.

Detailed Description
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All patients are treated with the paclitaxel releasing balloon Pantera Lux. The indication is in-stent restenosis in either bare metal stent (BMS) or drug eluting stent (DES). Clinical follow up visits at 1, 6 and 12 months. Angiographic follow up visit at 6 months.

Official Title
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Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis A Prospective, Multi-centre, Non-randomized Clinical Trial With Follow-up Investigations at 1, 6 and 12 Months

Conditions
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In-stent Coronary Artery Restenosis

Intervention / Treatment
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* Device: Paclitaxel Releasing Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient >/= 18 years Written patient informed consent available Patients with stable, unstable or documented silent angina pectoris Patient eligible for percutaneous coronary intervention Patient acceptable candidate for coronary artery bypass surgery Patients with a single restenotic lesion in a previously stented area of a coronary artery (irrelevant whether BMS or DES related) Target reference vessel diameter (visual estimation): 2 - 4 mm Target lesion length (visual estimation): 8 - 28 mm Target lesion stenosis (visual estimation): >/= 50% - < 100% Exclusion Criteria: Left ventricular ejection fraction of < 30% Visible thrombus in the target vessel visualized by angiography Myocardial infarction (STEMI/NSTEMI) within 72 hours of the intended treatment. Determination of CKMB and/or troponin T or I is required. Notes: Laboratory assessments to be done within 24 hours prior to intervention. Patients with CKMB and/or troponin T or I > 2 fold the upper limit of normal must not be included in the trial. Patients with planned major surgery within 3 months after planned coronary intervention and/or risk of either acetylsalicylic acid of clopidogrel cessation Lesion length longer than length of available treatment balloon Impaired renal function (serum creatinine > 2.0mg/dl or 177 micro mol/l, determined within 72 hours prior to intervention) Additional coronary lesions (restenotic or de novo) in the same vessel which requires treatment Totally occluded coronary artery (Mehran classification IV and TIMI flow 0) Target lesion located in vessel bifurcation Previous and/or planned brachytherapy of target vessel Target lesion located in left main coronary artery Stroke or TIA < 6 months prior to procedure Patient with signs of a cardiogenic shock Patient under ongoing systemic immunosuppressive therapy with paclitaxel or agents of the -limus group (i.e. sirolimus, tacrolimus, everolimus) Surgeries of any kind within 30 days prior to screening Patient with bleeding diathesis in whom anticoagulation or antiplatelet medication is contraindicated Known allergies to anti-platelet-, anticoagulation therapy, contrast media or paclitaxel Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required for females of child-bearing potential) Patient with a life expectancy of less than one year Patient currently enrolled in other investigational device or drug trial Patient with known incompliance to medical (antiplatelet, anticoagulation) therapy Patient not able or willing to adhere to follow-up visits including follow-up angiography

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel Releasing Balloon<br>Percutaneous coronary intervention with paclitaxel releasing balloon | Device: Paclitaxel Releasing Balloon<br>* Percutaneous coronary intervention with paclitaxel releasing balloon<br>* Other names: Pantera Lux;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent Late Lumen Loss | In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon. Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA). Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment Late Lumen Loss | In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal. Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA). Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany). | 6 months | 
| Cumulative Major Adverse Cardiac Events Rate (Composite of Cardiac Death, Non-fatal Myocardial Infarction, Clinically Driven Target Lesion Revascularization, Clinically Driven Target Vessel Revascularization) | All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee. Major Adverse Cardiac Events = MACE Myocardial Infarction = MI Target Lesion Revascularization = TLR Target Vessel Revascularization = TVR | 6 months | 
| Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR) | All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee. | 12 months | 
| In-stent Diameter Stenosis (%DS) | In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon. Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%. Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany). | 6 months | 
| In-segment Diameter Stenosis (%DS) | In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal. Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%. Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany). | 6 months | 
| Binary In-stent Restenosis | In-sent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon. Binary restenosis was defined as a ≥ 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA). Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%. Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany). | 6 months | 
| Binary In-segment Restenosis | In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal. Binary restenosis was defined as a ≥ 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA). Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%. Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany). | 6 months | 
| Technical Success | Technical success is defined as successful vascular access, completion of the endovascular procedure and immediate morphological success with < 30% residual diameter stenosis assessed by quantitative coronary angiography (QCA). Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%. Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany). | directly after intervention (after finalized treatment) | 
| Device Success | Device success defined as exact deployment of the device as documented by two different projections assessed by quantitative coronary angiography (QCA). Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany). | directly after intervention (after finalized treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paclitaxel, in-stent restenosis, BMS-ISR, DES-ISR, drug eluting balloon