Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- InnoRa GmbH
- Enrollment
- 70
- Locations
- 6
- Primary Endpoint
- late lumen loss in-segment
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon
Detailed Description
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon. Prospective, multicenter, randomized, single-blind, 70 patients. Experimental intervention: Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²). Control intervention: Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²). Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months. clinical follow up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical evidence of stable or unstable angina or a positive functional study
- •Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to \<70% diameter stenosis with positive functional test or symptom of ischemia)
- •Successful lesion preparation (no flow-limiting dissection or a residual stenosis \> 30%)
Exclusion Criteria
- •Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI)
- •Intolerance and / or allergy to Sirolimus
- •Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient:
- •Patients with an ejection fraction of \< 30 %
- •Reference vessel diameter (RVD) \< 2.5 mm
- •Contraindication for whichever necessary accompanying medication
Outcomes
Primary Outcomes
late lumen loss in-segment
Time Frame: 6 months
angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline
Secondary Outcomes
- MACE(at 6 and at 12 months)
- Procedural success(5 days)