Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

Study Overview
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Brief Summary
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The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon.

Detailed Description
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Prospective, controlled, multicenter, randomized, single-blind trial. The aim is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon. Patients are randomized to treatment by an AngioSculpt scoring balloon (no drug coating)or a drug coated AngioSculpt scoring balloon (paclitaxel 3.0 µg/mm²). Primary efficacy endpoint is late lumen loss in-segment at 6 months. Key secondary endpoints include procedural Success, MACE (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 6 months). Individual clinical endpoints include stent thrombosis (ARC), cardiac death, any death, target vessel myocardial infarction, any infarction, clinically driven target lesion revascularization, clinically driven target vessel revascularization, any revascularization.

Official Title
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Treatment of Coronary In-stent Restenosis by a Paclitaxel Coated AngioSculpt Scoring Balloon - a First-in-man Pilot Study

Conditions
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In-stent Arterial Restenosis

Intervention / Treatment
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* Device: uncoated AngioSculpt(R)
* Combination Product: Drug coated AngioSculpt(R)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age clinical evidence of stable or unstable angina or a positive functional study patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis) within previously placed bare metal stents (BMS) Exclusion Criteria: acute myocardial infarction within the past 72 hours chronic renal insufficiency with serum creatinine levels >2.0 mg per deciliter% known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or paclitaxel, and sensitivity to contrast media not amenable to premedication concomitant medical illness associated with a life-expectancy of less than two years stented segment length ≥30 mm, vessel diameter <2.5 mm, diameter stenosis <70%

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 AngioSculpt(R)<br>Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating) | Device: uncoated AngioSculpt(R)<br>* Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)<br>|
| Active Comparator: drug coated AngioSculpt(R)<br>Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²) | Combination Product: Drug coated AngioSculpt(R)<br>* Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late lumen loss in-segment | angiographic late lumen loss in-segment assessed by quantitative coronary angiography | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | <50% final DS and the absence of in-hospital MACE | participants will be followed for the duration of hospital stay, an expected average of 2 days | 
| Major adverse cardiovascular events | the occurence of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 6 months (before planned control angiography) | 6 months |