Actively Recruiting
Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-11-17
3000
Participants Needed
1
Research Sites
463 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing PCI with the Protégé paclitaxel-eluting drug-coated balloon
- Age 18 years or older
- Presence of a de novo lesion or in-stent restenosis in a native coronary artery or bypass graft suitable for PCI
- Reference vessel diameter between 2.0 and 4.5 mm
- Patient suitable for dual antiplatelet therapy (DAPT)
You will not qualify if you...
- Unable to provide informed consent
- Allergy to paclitaxel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
Research Team
I
Inge T Bosch
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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