Drug-coating Balloon Treatment in Coronary Artery Disease: a Prospective, Multicenter, Registry Study (ULTIMATE-DCB)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- target vessel failure (TVF) at 12 months
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Junjie Zhang
Vice chief of the department of cardiology
Nanjing First Hospital, Nanjing Medical University
Eligibility Criteria
Inclusion Criteria
- •Patients suitable for DCB treatment
Exclusion Criteria
- •Pregnancy
- •Contraindications to contrast media, antiplatelet therapy, or paclitaxel
- •Expected life less than 12 months
- •Cardiac shock
Outcomes
Primary Outcomes
target vessel failure (TVF) at 12 months
Time Frame: 12 months
TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target- vessel revascularization.
Secondary Outcomes
- Bleeding at 12 months(12 months)
- Parameter by quantitative coronary angiography at 7 months(7 months)
- Bailout drug-eluting stents (DES) implantation rate(During procedure)