REVERSE is a prospective, randomised, open-label, international multicentre trial. The objective is 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 enroll 1436 patients eligible for PCI at 20 investigational sites and patients will be followed up to 3 years after procedure.
Sponsor
Study objectives
To compare the safety and efficacy of drug-coated balloon treatment and drug-eluting stenting in patients with large coronary artery disease.
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
- CEC activities
- CEC and DSMB activities
- Contract management
- EDC and data management
- Monitoring activities
- Project management
- Regulatory submissions
- SAE Reporting
- Site management ( Bangladesh, Malaysia, Brunei,Thailand & Poland)
- Site qualification
- Statistical Analysis
Countries
South Korea, Malaysia, Singapore and Taiwan
Number of investigational sites
20
