Drug-coating Balloon Treatment in Coronary Artery Disease
- Conditions
- Coronary Artery Disease
- Interventions
- Device: DCB treatment
- Registration Number
- NCT04255563
- Brief Summary
Drug-coated balloon (DCB) is an alternative choice for patients with coronary artery disease (CAD). This study is to investigate the efficacy and safety of DCB treatment in patients with CAD.
- Detailed Description
This is a prospective, multi-center, registry to enroll patients undergoing DCB treatment.
All subjects undergoing DCB treatment will be enrolled in this study without strict inclusion and exclusion criteria. Data and images will be collected during the index procedure, and at the clinical and angiographic follow-up.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- Patients suitable for DCB treatment
- Pregnancy
- Contraindications to contrast media, antiplatelet therapy, or paclitaxel
- Expected life less than 12 months
- Cardiac shock
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description DCB treatment DCB treatment DCB (Sequent® Please) treatment will be performed for suitable patients with CAD.
- Primary Outcome Measures
Name Time Method target vessel failure (TVF) at 12 months 12 months TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target- vessel revascularization.
- Secondary Outcome Measures
Name Time Method Bleeding at 12 months 12 months bleeding
Parameter by quantitative coronary angiography at 7 months 7 months Late lumen loss
Bailout drug-eluting stents (DES) implantation rate During procedure Bailout DES implantation rate during procedure by angiographic criteria
Trial Locations
- Locations (1)
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China