Sponsor Name

 B.BRAUN MELSUNGEN AG AESCULAP DIVISION

Brief summary

REVERSE study is a 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.

The objective is to compare the safety and efficacy of drug-coated balloon treatment and drug-eluting stenting in patients with large coronary artery disease.

The objective is to enroll 1436  patients eligible for PCI at 19-21 investigational sites and patients will be followed up to 3 years after procedure.

Primary endpoints

The primary endpoint is the occurrence within 1 year of 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).

CERC Services

Clinical trial documentation,

Regulatory Submission,

Set-up activities (sites feasibility, contract management),

Project Management,

Monitoring,

Safety reporting,

Statistical Analysis

Clinical report

Countries

South Korea, Malaysia, Singapore, and Taiwan.

Number of investigational sites: 19-21 sites

Number of patients: 1436