Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

University Hospital, Saarland60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

In-stent Arterial Restenosis

Interventions

uncoated AngioSculpt(R)DEVICE

Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)

Drug coated AngioSculpt(R)COMBINATION_PRODUCT

Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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%

Locations (3)

Danta Pazzanese Heart Institute

São Paulo, Brazil

Internal Medicine III, UKS

Homburg Saar, Germany

Herzzentrum Leipzig

Leipzig, Germany

Outcomes

Primary Outcomes

late lumen loss in-segment

angiographic late lumen loss in-segment assessed by quantitative coronary angiography

Time frame: 6 months

Secondary Outcomes

Procedural Success

\<50% final DS and the absence of in-hospital MACE

Time frame: 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)

Time frame: 6 months

Data from ClinicalTrials.gov

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