Trials / Recruiting
RecruitingNCT07231835
Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons
RECORD-DCB: Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,000 (estimated)
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary aim of this registry is to systematically collect and analyze real-world data on all patients undergoing PCI with the Protégé paclitaxel-eluting DCB to evaluate procedural outcomes, long-term efficacy, and safety across various clinical indications. This registry aims to assess the clinical effectiveness of DCB therapy across diverse patient populations, including those with stable coronary artery disease (CAD) and acute coronary syndromes (ACS), as well as various lesion subsets, encompassing (but not limited to) in-stent restenosis (ISR), de novo coronary lesions, small vessel disease, bifurcation and calcified lesions, coronary bypass graft lesions, and patients at high risk of bleeding. Additionally, the study aims to identify predictors of success, complications, and optimal treatment strategies to further refine the use of DCBs.
Conditions
- Percutaneous Coronary Intervention (PCI)
- Drug Coated Balloon
- Paclitaxel
- CAD - Coronary Artery Disease
- ACS (Acute Coronary Syndrome)
- Stable Coronary Artery Disease (CAD), Myocardial Infarction
Timeline
- Start date
- 2025-11-11
- Primary completion
- 2029-09-30
- Completion
- 2034-09-30
- First posted
- 2025-11-17
- Last updated
- 2025-11-17
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT07231835. Inclusion in this directory is not an endorsement.