NCT07363161

Drug-coated Balloon (DCB) vs. Drug-eluting Stent (DES) in High-risk Patients With Coronary Artery Disease (CAD)

BASel Kosten-Effektivitäts-Trial: Drug-coated BALLoon vs. Drug-eluting Stent Strategy in High-risk Patients With Coronary Artery Disease

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,184 (estimated)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this randomized, multicenter, international, open-label clinical trial is to demonstrate that, in the context of percutaneous coronary intervention for complex coronary artery disease, a SeQuent® SCB interventional strategy is non-inferior to a new-generation DES strategy in terms of a 12- and 36-month composite of Target Vessel Failure (TVF), that includes: * cardiovascular death (CV death), * target vessel related MI (TV-MI), * clinically indicated target vessel revascularization (ci-TVR), * bleeding according to Bleeding Academic Research Consortium (BARC) Types 3-5. Eligible subjects will be assigned in a 1:1 ratio to receive treatment of all lesions with either the SeQuent® SCB-based strategy or a DES-based strategy. The randomization will be performed prior to the index procedure once signed informed consent has been obtained and all eligibility criteria have been confirmed. All Subjects will be followed for clinical outcomes at 3 months, 1, 2, and 3 years. A subset of 138 randomized patients will undergo control angiography after one-year clinical follow-up (+1 month). An independent core laboratory will analyze all baseline angiograms. If, at 36 months, the non-inferiority of the SeQuent® SCB strategy compared to the DES strategy is achieved, superiority in terms of TVF and BARC Type 3-5 bleeding will be tested. An optional extension of follow-up to 6 years may be implemented based on interim results and the joint decision of the Steering Committee and the Sponsor. Details regarding this optional extension are provided in the Clinical Investigation Plan.

Conditions

• Coronary Artery Disease (CAD)

Interventions

Type	Name	Description
DEVICE	PCI	PCI with SeQuent® SCB
DEVICE	PCI	PCI with DES

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-06-01
• Completion: 2031-03-01
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: Switzerland