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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: SCB PTCA; Device: PCB PTCA

• Registration Number: NCT04017364
• 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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-12
• Primary Completion: 2020-08-30
• Study Completion: 2021-01-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-27

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
PTCA of coronary de novo lesion SCB	SCB PTCA	Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²)
PTCA of coronary de novo lesion PCB	PCB PTCA	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
MACE	at 6 and at 12 months	combined endpoint of: cardiac death, target vessel myocardial infarction, and TLR target lesion revascularization in-hospital at 6 and at 12 months
Procedural success	5 days	combined endpoint of: \< 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE

Trial Locations

Locations (6)

Sarawak Heart Centre; 🇲🇾 Kuching, Malaysia

Hospital Pulau Pinang; 🇲🇾 Pulau Pinang, Malaysia

Sabah Heart Centre, Queen Elizabeth Hospital II; 🇲🇾 Kota Kinabalu, Malaysia

Cardio Vascular Sentral; 🇲🇾 Kuala Lumpur, Malaysia

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia

National Heart Institute; 🇲🇾 Kuala Lumpur, Malaysia