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

NCT05846893 | Active Not Recruiting DMC

• 1 other identifier: AAG-G-H-2124
• Study Type: interventional
• Target: 1,436
• Locations: 4 countries
• Sites: 21

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.

Conditions

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

Keywords

de novo; large vessel; coronary artery disease; cardiovascular disease; coronary occlusion; heart disease; acute coronary syndrome; angina; ischemia; stenosis; percutaneous coronary intervention; angioplasty; drug-coated balloon; drug-eluting stent; SeQuent Please; randomised trial

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

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

Study Arms (2)

SeQuent® Please NEO drug-coated balloon catheter

EXPERIMENTAL

Device: SeQuent® Please NEO drug-coated balloon catheter

Current-generation drug-eluting stent

EXPERIMENTAL

Device: Current-generation drug-eluting stent

Interventions

SeQuent® Please NEO drug-coated balloon catheter DEVICE

Treatment of coronary artery disease with SeQuent® Please NEO for de novo lesions in native large coronary arteries

SeQuent® Please NEO drug-coated balloon catheter

Current-generation drug-eluting stent DEVICE

Treatment of coronary artery disease with current-generation drug-eluting stent for de novo lesions in native large coronary arteries

Current-generation drug-eluting stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• B. Braun Medical Industries Sdn. Bhd.: lead
• B. Braun Melsungen AG: collaborator
• Ulsan University Hospital: collaborator
• European Cardiovascular Research Center: collaborator
• Seoul National University Hospital: collaborator
• Universität des Saarlandes: collaborator

Study Sites (21)

National Heart Institute Malaysia

Kuala Lumpur, Kuala Lumpur, 50400, Malaysia

Location

Cardiac Vascular Sentral Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, 50470, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Queen Elizabeth II Hospital

Kota Kinabalu, Sabah, 88300, Malaysia

Location

Sarawak Heart Center

Kuching, Sarawak, 94300, Malaysia

Location

Sultan Idris Shah Serdang Hospital

Kajang, Selangor, 43000, Malaysia

Location

Tan Tock Seng Hospital

Novena, 308433, Singapore

Location

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

Khoo Teck Puat Hospital

Singapore, 768828, Singapore

Location

Keimyung University Dongsan Hospital

Daegu, Daegu, 42601, South Korea

Location

Kangwon National University Hospital

Chuncheon, Gangwon-do, 24289, South Korea

Location

Chonnam National University Hospital

Donggu, Gwangju, 61469, South Korea

Location

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, 15355, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, 10380, South Korea

Location

Gyeongsang National University Changwon Hospital

Changwon, Gyeongsangnam-do, 51472, South Korea

Location

Kangbuk Samsung Hospital

Seoul, Seoul, 13631, South Korea

Location

Ulsan University Hospital

Donggu, Ulsan, 44033, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Far Eastern Memorial Hospital

New Taipei City, 220216, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan, 33305, Taiwan

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Acute Coronary Syndrome; Coronary Stenosis; Cardiovascular Diseases; Coronary Occlusion; Heart Diseases; Angina Pectoris; Ischemia; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Pathological Conditions, Anatomical

Study Officials

• Eun-Seok Shin, MD, Ph.D

  Ulsan University Hospital

  STUDY CHAIR

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): May 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (3); TW (3); MY (6); KR (9)