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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,436
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
National Heart Institute Malaysia
Kuala Lumpur, Kuala Lumpur, Malaysia
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)
Time frame: At 1 year
All-cause death
Time frame: At 12, 24, and 36 months
Non-fatal myocardial infarction
Time frame: At 12, 24, and 36 months
Clinically driven target vessel revascularization
Time frame: At 12, 24, and 36 months
Major bleeding (BARC type 3 to 5)
Time frame: At 12, 24, and 36 months
Cardiac death
Time frame: At 12, 24, and 36 months
Target vessel myocardial infarction
Time frame: At 12, 24, and 36 months
Periprocedural myocardial infarction
Time frame: At 12, 24, and 36 months
Target lesion revascularization
Time frame: At 12, 24, and 36 months
Stent/lesion thrombosis in treated lesion defined according to the Academic Research Consortium-2 (ARC-2) criteria
Time frame: At 12, 24, and 36 months
Rehospitalization related to study endpoints
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Cardiac Vascular Sentral Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Queen Elizabeth II Hospital
Kota Kinabalu, Sabah, Malaysia
Sarawak Heart Center
Kuching, Sarawak, Malaysia
Sultan Idris Shah Serdang Hospital
Kajang, Selangor, Malaysia
Tan Tock Seng Hospital
Novena, Singapore
National Heart Centre Singapore
Singapore, Singapore
Khoo Teck Puat Hospital
Singapore, Singapore
Keimyung University Dongsan Hospital
Daegu, Daegu, South Korea
...and 11 more locations
Rate of hospitalization related to study endpoints
Time frame: At 30 days, 12 months, 24 months, and 36 months
Stroke (ischemic and hemorrhagic)
Number of participants with stroke (ischemic and hemorrhagic)
Time frame: At 12, 24, and 36 months
Total angioplasty procedure time
Time frame: During the index procedure
Fluoroscopy time of the angioplasty procedure
Time frame: During the index procedure
Contrast volume of the angioplasty procedure
Time frame: During the index procedure
Number of devices (DCB/ DES) used for PCI treatment
Time frame: During the index procedure