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

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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: PCB PTCA; Device: SCB PTCA

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kota Kinabalu, Malaysia, 88300
    • Sabah Heart Centre, Queen Elizabeth Hospital II
  • Kuala Lumpur, Malaysia, 50603
    • University Malaya Medical Centre
  • Kuala Lumpur, Malaysia, 50400
    • National Heart Institute
  • Kuala Lumpur, Malaysia, 50470
    • Cardio Vascular Sentral
  • Kuching, Malaysia, 94300
    • Sarawak Heart Centre
  • Pulau Pinang, Malaysia, 10990
    • Hospital Pulau Pinang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Device: PCB PTCA; Predilatation of coronary de-novo stenosis followed by a PCB
Experimental: 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)	Device: SCB PTCA; Predilatation of coronary de-novo stenosis followed by a SCB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
late lumen loss in-segment	angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	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	5 days
MACE	combined endpoint of: cardiac death, target vessel myocardial infarction, and TLR target lesion revascularization in-hospital at 6 and at 12 months	at 6 and at 12 months

Collaborators and Investigators

• Sponsor: InnoRa GmbH

Publications and helpful links

General Publications

• Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040.
• Ahmad WAW, Nuruddin AA, Abdul Kader MASK, Ong TK, Liew HB, Ali RM, Mahmood Zuhdi AS, Ismail MD, Yusof AKM, Schwenke C, Kutschera M, Scheller B. Treatment of Coronary De Novo Lesions by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2022 Apr 11;15(7):770-779. doi: 10.1016/j.jcin.2022.01.012. Epub 2022 Mar 16.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Paclitaxel; drug coated balloon; sirolimus
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: SI-DN-MALAYSIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No