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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: PTCA of coronary de novo lesion SCB; Device: PTCA of coronary de novo lesion PCB

• Registration Number: NCT03908450
• Lead Sponsor: InnoRa GmbH

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

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)

Study Timeline

• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-07
• Study First Posted: 2019-04-09
• Study Start: 2019-09-25
• Primary Completion: 2023-04-30
• Study Completion: 2023-07-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental intervention	PTCA of coronary de novo lesion SCB	Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²)
Control intervention	PTCA of coronary de novo lesion PCB	Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²)

Primary Outcome Measures

Name	Time	Method
late lumen loss in-segment	6 months	angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline

Secondary Outcome Measures

Name	Time	Method
Procedural Success	in hospital	\< 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE
MACE MACE	at 6 and at 12 months	cardiac death, target vessel myocardial infarction, and TLR target lesion revascularization in-hospital at 6 and at 12 months

Trial Locations

Locations (4)

Klinik für Innere Medizin III - Kardiologie Paul Gerhardt Stift; 🇩🇪 Wittenberg, Germany

Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes; 🇩🇪 Homburg/Saar, Saarland, Germany

Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden; 🇩🇪 Dresden, Germany

Universitätsspital Basel; 🇨🇭 Basel, Switzerland