Overview

This trial is active, not recruiting.

Condition in-stent arterial restenosis
Treatments uncoated angiosculpt(r), drug coated angiosculpt(r)
Phase phase 3
Sponsor University Hospital, Saarland
Start date December 2011
End date December 2013
Trial size 60 participants
Trial identifier NCT01495533, FIM-DCA-01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Placebo Comparator)
Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)
uncoated angiosculpt(r)
Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)
(Active Comparator)
Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²)
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)

Primary Outcomes

Measure
late lumen loss in-segment
time frame: 6 months

Secondary Outcomes

Measure
Procedural Success
time frame: participants will be followed for the duration of hospital stay, an expected average of 2 days
Major adverse cardiovascular events
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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%

Additional Information

Official title Treatment of Coronary In-stent Restenosis by a Paclitaxel Coated AngioSculpt Scoring Balloon - a First-in-man Pilot Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by University Hospital, Saarland.