Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR I)

Study Overview
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Brief Summary
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The PACCOCATH ISR study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent restenosis.

Detailed Description
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Background: Drug-eluting stents have shown promising anti-restenotic effects in clinical trials. It may be preferable, however, to avoid the stent-in-stent approach in treating in-stent restenosis (ISR). In prior animal trials, we demonstrated a highly significant reduction of neointimal formation by drug-eluting balloon catheters (DEB). The aim of the PACCOCATH ISR study is to investigate the novel DEB in the treatment of ISR. Methods and results: The PACCOCATH ISR study is a randomized, double-blind German multicenter trial on the efficacy and tolerance of the DEB in coronary ISR. Patients are randomized to rePTCA of ISR either using the coated PTCA balloon (3 µg paclitaxel/mm² balloon surface) or a non-coated balloon of the same type (n=52 patients). Balloon inflation time is 60 seconds in both cases. Major inclusion criteria are an ISR in a coronary artery with a diameter stenosis of at least 70%, < 25 mm length, and a vessel diameter of 2.5 to 3.5 mm. The primary endpoint is late lumen loss after 6 months (independent angiographic core lab). Secondary endpoints are binary restenosis rate and major adverse cardiac events.

Official Title
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Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons

Conditions
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Coronary Restenosis

Intervention / Treatment
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* Device: PTCA
* Combination Product: paclitaxel coated balloon catheter (device with drug)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Clinical evidence of stable or unstable angina or a positive functional study Single, restenotic lesion in a stented coronary artery (allowed are multiple lesions but only the target lesion is amenable for percutaneous intervention, i.e. no 'staged' procedures involving non-target lesions) Diameter stenosis > 70% (visual estimate) Stented segment length < 25 mm Vessel diameter => 2.5 mm Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization Signed patient informed consent form Patients and treating physicians agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol Exclusion Criteria: Left ventricular ejection fraction of < 30% Target lesion/vessel with any of the following characteristics: Clear angiographic calcification in the target lesion or greater than mild calcification in the proximal vessel (minimally radiopaque densities that are discrete and non-linear). Visible thrombus proximal to the lesion. Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated. Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy causing the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years). Severe chronic renal insufficiency. Significant gastrointestinal (GI) bleed within the past six months. History of bleeding diathesis or coagulopathy or will refuse blood transfusions. Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and/or requires additional anti-platelet and/or anti-coagulation treatment. Participating in another device or drug study within the last 6 months

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Uncoated Angioplasty<br>PTCA of ISR | Device: PTCA<br> <br> |
| Experimental: DCB Angioplasty<br>DCB PTCA of ISR | Combination Product: paclitaxel coated balloon catheter (device with drug)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| angiographic late lumen loss | angiographic late lumen loss | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| binary restenosis rate | binary restenosis rate | 6 months | 
| major adverse cardiac events | major adverse cardiac events | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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in stent restenosis, paclitaxel coated balloon catheter, paccocath, drug eluting balloon