STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial

NARecruitingINTERVENTIONAL
Enrollment

2,700

Participants

Timeline

Start Date

October 15, 2023

Primary Completion Date

December 30, 2025

Study Completion Date

December 30, 2025

Conditions
Drug-coated BalloonDrug-eluting StentDe Novo Stenosis
Interventions
DEVICE

Drug-coated balloon (Bingo© [Paclitaxel-coated Balloon], Yinyi Ltd., China)

"* Patients treated with DCB will receive dual antiplatelet therapy (DAPT, aspirin plus P2Y12 inhibitor) for 1-3 months, followed by long-term single antiplatelet therapy (SAPT, aspirin or P2Y12 inhibitor).~* Patients with bailout stenting will generally receive DAPT for 6 months unless deemed as with high ischemic and/or bleeding risks (see special consideration in Drug-eluting stent Arm), and then followed by long-term SAPT."

DEVICE

Drug-eluting stent

"* Patients treated with DES will generally receive DAPT for 6 months unless deemed as with high ischemic and/or bleeding risks (see special consideration below), and then followed by long-term SAPT.~* Special consideration:~ 1. Patients will take additional assessment (both DAPT score and PRECISE-DAPT score) to determine their personalized duration of DAPT.~ 2. The duration of DAPT is extended to 12 months for patients diagnosed as acute coronary syndrome within 12 months.~ 3. If anticoagulation is indicated, patient will receive a short-term triple antithrombotic therapy (generally 1 to 4 weeks), followed by a variable length of dual antithrombotic therapy (oral anticoagulation (OAC) plus a single antiplatelet agent, preferably clopidogrel) and subsequent long-term OAC mono-therapy. The duration of dual antithrombotic therapy is determined by bleeding risks (HAS-BLED score) according to current guidelines."

Trial Locations (1)

100037

RECRUITING

Fuwai Hospital, National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences, Beijing

All Listed Sponsors
lead

China National Center for Cardiovascular Diseases

OTHER_GOV