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

InnoRa

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: PTCA of coronary de novo lesion PCB; Device: PTCA of coronary de novo lesion SCB

Study type: Interventional

Funder types: Industry

Identifiers

NCT03908450

SI-DN-01

Details and patient eligibility

About

To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon

Full 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)

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

iopromide)

• Patients with an ejection fraction of < 30 %
• Reference vessel diameter (RVD) < 2.5 mm
• Contraindication for whichever necessary accompanying medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Control intervention

Active Comparator group

Description:

Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²)

Treatment:

Device: PTCA of coronary de novo lesion PCB

Experimental intervention

Experimental group

Description:

Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²)

Treatment:

Device: PTCA of coronary de novo lesion SCB