Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

Phase 3

Completed

• Conditions: In-stent Arterial Restenosis
• Interventions: Combination Product: Drug coated AngioSculpt(R); Device: uncoated AngioSculpt(R)

• Registration Number: NCT01495533
• Lead Sponsor: University Hospital, Saarland

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-20
• Primary Completion: 2013-12
• Study Completion: 2014-07
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug coated AngioSculpt(R)	Drug coated AngioSculpt(R)	Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²)
uncoated AngioSculpt(R)	uncoated AngioSculpt(R)	Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)

Primary Outcome Measures

Name	Time	Method
late lumen loss in-segment	6 months	angiographic late lumen loss in-segment assessed by quantitative coronary angiography

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Danta Pazzanese Heart Institute; 🇧🇷 São Paulo, Brazil

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany

Internal Medicine III, UKS; 🇩🇪 Homburg Saar, Germany