Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

University Hospital, Saarland

Status and phase: Completed; Phase 3

Conditions: In-stent Arterial Restenosis

Treatments: Combination Product: Drug coated AngioSculpt(R); Device: uncoated AngioSculpt(R)

Study type: Interventional

Funder types: Other

Identifiers

NCT01495533

FIM-DCA-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

uncoated AngioSculpt(R)

Active Comparator group

Description:

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

Treatment:

Device: uncoated AngioSculpt(R)

drug coated AngioSculpt(R)

Active Comparator group

Description:

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

Treatment:

Combination Product: Drug coated AngioSculpt(R)