NCT06084000

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,700 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, randomized controlled study meant to compare the safety and efficacy of scheduled drug-coated balloon (DCB) and conventional drug-eluting stent (DES) strategy in the treatment of de novo lesions of large coronary vessel with diameter larger than 2.75 mm. The trial was designed to provide high-quality evidence for expanding the clinical indications of DCB, and to explore a better way for coronary intervention based on DCB.

Conditions

• Drug-coated Balloon
• Drug-eluting Stent
• De Novo Stenosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-15
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-10-16
• Last updated: 2023-10-17

Locations

1 site across 1 country: China