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

B. Braun Medical Industries Sdn. Bhd.19 sites in 4 countries1,436 target enrollmentSeptember 7, 2023

ConditionsCoronary Artery Disease Myocardial Ischemia Acute Coronary Syndrome Coronary Stenosis De Novo Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: B. Braun Medical Industries Sdn. Bhd.
Enrollment: 1436
Locations: 19
Primary Endpoint: Net Adverse Clinical Event (NACE)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 7, 2023

End Date

September 2028

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

B. Braun Medical Industries Sdn. Bhd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient-related:
•Patient must be ≥ 18 years of age
•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
•(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 \[unstable angina or non-ST-elevation myocardial infarction (NSTEMI) or uneventful STEMI (≥ 48 hours after primary PCI and no sign of thrombus in lesion(s) to treat)\]
•Patient with lesions suitable for PCI with a DCB (and/or DES) according to the Instructions for Use
•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:
•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
•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.

Exclusion Criteria

•Patient-related:
•Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient: Iopromide)
•Severe allergy to contrast media
•Recent STEMI (ongoing or \< 48 hours after primary PCI and/or has sign of thrombus in lesion(s) to treat)
•NSTEMI hemodynamically unstable
•Known left ventricular ejection fraction of \<30%
•Inability to take dual antiplatelet therapy or anticoagulation, or single antiplatelet therapy for at least six months
•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)
•Patient with concomitant medical illnesses that require cytostatic, radiation therapy or renal replacement therapy
•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

Outcomes

Primary Outcomes

Net Adverse Clinical Event (NACE)

Time Frame: At 1 year

Net adverse clinical event (NACE): a composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, or major bleeding (BARC type 3 to 5)

Secondary Outcomes

Target vessel myocardial infarction(At 12, 24, and 36 months)
Fluoroscopy time of the angioplasty procedure(During the index procedure)
Contrast volume of the angioplasty procedure(During the index procedure)
All-cause death(At 12, 24, and 36 months)
Clinically driven target vessel revascularization(At 12, 24, and 36 months)
Major bleeding (BARC type 3 to 5)(At 12, 24, and 36 months)
Periprocedural myocardial infarction(At 12, 24, and 36 months)
Target lesion revascularization(At 12, 24, and 36 months)
Rehospitalization related to study endpoints(At 30 days, 12 months, 24 months, and 36 months)
Stroke (ischemic and hemorrhagic)(At 12, 24, and 36 months)
Non-fatal myocardial infarction(At 12, 24, and 36 months)
Stent/lesion thrombosis in treated lesion defined according to the Academic Research Consortium-2 (ARC-2) criteria(At 12, 24, and 36 months)
Total angioplasty procedure time(During the index procedure)
Number of devices (DCB/ DES) used for PCI treatment(During the index procedure)
Cardiac death(At 12, 24, and 36 months)