Loading clinical trials...

Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease | Clinical Trials | Clareo Health

RECRUITINGNA

Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease

Randomised Trial of Drug-Coated Balloon Versus Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease

NCT05846893•B. Braun Medical Industries Sdn. Bhd.

View on ClinicalTrials.gov

Summary

Prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery disease.

Detailed Description

Although several reports suggested that DCB application was safe for larger coronary artery lesions and showed good long-term outcomes, there is limited randomised controlled trial (RCT) data on the safety and efficacy of DCB in large coronary artery disease. Therefore, the study aims to demonstrate the non-inferiority of the drug-coated balloon (DCB) treatment against current-generation drug-eluting stenting (DES) in patients with de novo lesions in large coronary artery disease (reference vessel diameter ≥3.0 mm by visual estimation). The hypothesis of the study is the clinical outcomes of patients treated with DCB are non-inferior to those treated with current-generation DES.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient-related:
•1. Patient must be ≥ 18 years of age
•2. Patient is able to verbally confirm understanding of the study aim, risks, benefits, and treatment alternatives of receiving DCB or DES and he/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure
•3. (i) Clinical evidence of angina, and/or (ii) an abnormal functional study demonstrating myocardial ischemia due to the target lesion(s), or (iii) acute coronary syndrome \[unstable angina or non-ST-elevation myocardial infarction (NSTEMI) or uneventful STEMI (≥ 48 hours after primary PCI and no sign of thrombus in lesion(s) to treat)\]
•4. Patient with lesions suitable for PCI with a DCB (and/or DES) according to the Instructions for Use
•5. Patient is able to comply with the study protocol and agrees to undergo the clinical follow-up of 30 days, 6 months, 12 months, 24 months, and 36 months
•Lesion-related:
•1. Presence of significant de novo large vessel coronary artery disease (reference vessel diameter ≥3.0 mm by visual estimation) with either ≥ 70% diameter stenosis or intermediate ≥ 50% to \<70% diameter stenosis with abnormal functional test or symptom of ischemia
•2. Successful lesion preparation. For randomisation, the lesion must satisfy the following criteria after optimal balloon angioplasty: no flow-limiting dissection (TIMI=3), and residual stenosis is ≤ 30%
•Multivessel disease with two or more vessels showing diameter stenosis of 50% or more is not an exclusion as long as it fulfills all study's eligibility criteria.
+1 more criteria

Exclusion Criteria

•Patient-related:
•1. Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient: Iopromide)
•2. Severe allergy to contrast media
•3. Recent STEMI (ongoing or \< 48 hours after primary PCI and/or has sign of thrombus in lesion(s) to treat)
•4. NSTEMI hemodynamically unstable
•5. Known left ventricular ejection fraction of \<30%
•6. Inability to take dual antiplatelet therapy or anticoagulation, or single antiplatelet therapy for at least six months
•7. Non-cardiac co-morbid conditions that may result in protocol non-compliance and inability of patient to complete the study (per the site investigator's medical judgment)
•8. Patient with concomitant medical illnesses that require cytostatic, radiation therapy or renal replacement therapy
•9. Patient who is currently/ planning to participate in another clinical trial when such participation could confound the treatment or outcomes of this study, except for observational registry
+11 more criteria

Locations (19)

Queen Elizabeth II Hospital

Kota Kinabalu, Sabah, Malaysia

Sarawak Heart Center

Kuching, Sarawak, Malaysia

Sultan Idris Shah Serdang Hospital

Kajang, Selangor, Malaysia

National Heart Institute Malaysia

Kuala Lumpur, Malaysia

Cardiac Vascular Sentral Kuala Lumpur

Kuala Lumpur, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Tan Tock Seng Hospital

Novena, Singapore

National Heart Centre Singapore

Singapore, Singapore

Khoo Teck Puat Hospital

Singapore, Singapore

Kangwon National University Hospital

Chuncheon, Gangwon-do, South Korea

Key Dates

Start Date

September 7, 2023

Primary Completion Date

October 1, 2026

Completion Date

September 1, 2028

Last Updated

November 5, 2024

Enrollment

1,436

ESTIMATED participants

Conditions

Coronary Artery DiseaseMyocardial IschemiaAcute Coronary SyndromeCoronary StenosisDe Novo Stenosis

Interventions

SeQuent® Please NEO drug-coated balloon catheter

DEVICE

Current-generation drug-eluting stent

DEVICE

Contacts

Hooi Sian Eng, Ph.D

CONTACT

+60-12-428-2880 hooi.eng@bbraun.com

Philip Steen, MD

CONTACT

+49-30-568207-124 philip.steen@bbraun.com

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

NCT05681702

Coronary Artery Disease

View study

RECRUITING

"Erectile Function After PCI in MI and Non-MI Patients"

NCT07444697

Erectile DisfunctionCoronary Artery Disease (CAD)+3 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease

Inclusion Criteria

Exclusion Criteria

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

"Erectile Function After PCI in MI and Non-MI Patients"

Drug-Coated Balloon Primary PCI in ST-Segment Elevation Myocardial Infarction

Evaluation Through Innovative Examinations of Intestinal Dysbiosis Status in Patients Diagnosed With Cardiovascular Diseases and Evaluation of the Efficacy of Natural and Probiotic Extracts in the Non-pharmacological Approach to Improving Intestinal Dysbiosis Status.

Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease

Product Surveillance Registry