NCT03908450

Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: InnoRa GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Key inclusion criteria: \> 18 years of age, 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%). Key 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: iopromide), Patients with an ejection fraction of \< 30 %, Reference vessel diameter (RVD) \< 2.5 mm, Contraindication for whichever necessary accompanying medication. Primary efficacy endpoint: late lumen loss in-segment at 6 months. Key secondary endpoints: Procedural Success: \< 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE. MACE: cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization in-hospital at 6 and at 12 months Individual clinical endpoints at 6 and at 12 months: cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, (stenosis ≥ 50% at follow-up angiography)

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	PTCA of coronary de novo lesion PCB	PTCA of coronary de novo lesion with drug coated balloon
DEVICE	PTCA of coronary de novo lesion SCB	PTCA of coronary de novo lesion with drug coated balloon

Timeline

• Start date: 2019-09-25
• Primary completion: 2023-04-30
• Completion: 2023-07-31
• First posted: 2019-04-09
• Last updated: 2024-02-15

Locations

4 sites across 2 countries: Germany, Switzerland