Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
REVERSE
Randomised Trial of Drug-Coated Balloon Versus Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
1 other identifier
interventional
1,436
4 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Sep 2023
Longer than P75 for not_applicable coronary-artery-disease
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedStudy Start
First participant enrolled
September 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
November 5, 2024
November 1, 2024
3.1 years
April 11, 2023
November 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Net Adverse Clinical Event (NACE)
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)
At 1 year
Secondary Outcomes (15)
All-cause death
At 12, 24, and 36 months
Non-fatal myocardial infarction
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
Cardiac death
At 12, 24, and 36 months
- +10 more secondary outcomes
Other Outcomes (8)
Late lumen loss (LLL)
At 9-12 months post-procedure
Percentage of diameter stenosis
At 9-12 months post-procedure
Minimal lumen diameter
At 9-12 months post-procedure
- +5 more other outcomes
Study Arms (2)
SeQuent® Please NEO drug-coated balloon catheter
EXPERIMENTALCurrent-generation drug-eluting stent
EXPERIMENTALInterventions
Treatment of coronary artery disease with SeQuent® Please NEO for de novo lesions in native large coronary arteries
Treatment of coronary artery disease with current-generation drug-eluting stent for de novo lesions in native large coronary arteries
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
- Pregnancy or lactation
- Patient under administrative or judicial custody
- Lesion-related:
- Small vessel disease, defined as \<3.0 mm of reference vessel diameter by visual estimation
- In-stent restenosis lesions for study lesions
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- B. Braun Medical Industries Sdn. Bhd.lead
- B. Braun Melsungen AGcollaborator
- Ulsan University Hospitalcollaborator
- European Cardiovascular Research Centercollaborator
- Seoul National University Hospitalcollaborator
- Universität des Saarlandescollaborator
Study Sites (19)
Queen Elizabeth II Hospital
Kota Kinabalu, Sabah, 88300, Malaysia
Sarawak Heart Center
Kuching, Sarawak, 94300, Malaysia
Sultan Idris Shah Serdang Hospital
Kajang, Selangor, 43000, Malaysia
National Heart Institute Malaysia
Kuala Lumpur, 50400, Malaysia
Cardiac Vascular Sentral Kuala Lumpur
Kuala Lumpur, 50470, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Tan Tock Seng Hospital
Novena, 308433, Singapore
National Heart Centre Singapore
Singapore, 169609, Singapore
Khoo Teck Puat Hospital
Singapore, 768828, Singapore
Kangwon National University Hospital
Chuncheon, Gangwon-do, 24289, South Korea
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355, South Korea
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, 10380, South Korea
Gyeongsang National University Changwon Hospital
Changwon, Gyeongsangnam-do, 51472, South Korea
Ulsan University Hospital
Donggu, Ulsan, 44033, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Kangbuk Samsung Hospital
Seoul, 13631, South Korea
Far Eastern Memorial Hospital
New Taipei City, 220216, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Chang Gung Memorial Hospital
Taoyuan District, 33305, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eun-Seok Shin, MD, Ph.D
Ulsan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2023
First Posted
May 6, 2023
Study Start
September 7, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
September 1, 2028
Last Updated
November 5, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share