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

Not Applicable

Recruiting

• Conditions: Coronary Stenosis; Acute Coronary Syndrome; Coronary Artery Disease; Myocardial Ischemia; De Novo Stenosis
• Interventions: Device: Current-generation drug-eluting stent; Device: SeQuent® Please NEO drug-coated balloon catheter

• Registration Number: NCT05846893
• Lead Sponsor: B. Braun Medical Industries Sdn. Bhd.

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.

Study Timeline

• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-26
• Study First Posted: 2023-05-06
• Study Start: 2023-09-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-03
• Last Update Posted: 2024-11-05
• Primary Completion: 2026-10
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1436

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.

• In diffuse lesion, inclusion is possible if the proximal reference vessel diameter is 3.0 mm or more.

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
  10. Pregnancy or lactation
  11. Patient under administrative or judicial custody

• Lesion-related:

  1. Small vessel disease, defined as <3.0 mm of reference vessel diameter by visual estimation

  2. In-stent restenosis lesions for study lesions

  3. Patient will be excluded if meet any of the following angiographic exclusion criteria after lesion preparation:

     (i) Flow limiting dissection with TIMI flow < III (ii) Residual diameter stenosis >30%

     * The case of persistent ischemic symptoms/signs is up to the operator's decision

  4. Lesions which are untreatable with PCI or other interventional techniques and coronary artery spasm in the absence of a significant stenosis

  5. Left main disease or aorta-ostial lesion requiring revascularization

  6. Severely calcified or tortuous vessels precluding DCB or DES application

  7. Prior Coronary Artery Bypass Graft (CABG)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Current-generation drug-eluting stent	Current-generation drug-eluting stent	-
SeQuent® Please NEO drug-coated balloon catheter	SeQuent® Please NEO drug-coated balloon catheter	-

Primary Outcome Measures

Name	Time	Method
Net Adverse Clinical Event (NACE)	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 Outcome Measures

Name	Time	Method
All-cause death	At 12, 24, and 36 months
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
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	Rate of hospitalization related to study endpoints
Stroke (ischemic and hemorrhagic)	At 12, 24, and 36 months	Number of participants with stroke (ischemic and hemorrhagic)
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

Trial Locations

Locations (19)

Kangwon National University Hospital; 🇰🇷 Chuncheon, Gangwon-do, Korea, Republic of

Korea University Ansan Hospital; 🇰🇷 Ansan-si, Gyeonggi-do, Korea, Republic of

Queen Elizabeth II Hospital; 🇲🇾 Kota Kinabalu, Sabah, Malaysia

Sarawak Heart Center; 🇲🇾 Kuching, Sarawak, Malaysia

Inje University Ilsan Paik Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Keimyung University Dongsan Hospital; 🇰🇷 Daegu, Korea, Republic of

Gyeongsang National University Changwon Hospital; 🇰🇷 Changwon, Gyeongsangnam-do, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Donggu, Ulsan, Korea, Republic of

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of

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

Far Eastern Memorial Hospital; 🇨🇳 New Taipei City, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan