Outcomes after PCI using the Protégé paclitaxel drug-coated balloon.
RECORD-DCB: Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT07231835
This registry will collect real-world data to see if the Protégé paclitaxel drug-coated balloon works well and is safe for adults having PCI for coronary artery disease or acute coronary syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT07231835 on ClinicalTrials.gov |
What this trial studies
This observational registry collects systematic, real-world data on adults undergoing percutaneous coronary intervention (PCI) using the Protégé paclitaxel-eluting drug-coated balloon (DCB). It enrolls patients with de novo lesions or in-stent restenosis in native coronaries or bypass grafts with reference vessel diameters of 2.0–4.5 mm who are suitable for dual antiplatelet therapy. The registry will track procedural outcomes, long-term efficacy, and safety across lesion subsets including small vessels, bifurcations, calcified lesions, and graft disease. Collected data will be analyzed to identify predictors of success and complications and to inform optimal treatment strategies for diverse clinical presentations such as stable CAD and ACS.
Who should consider this trial
Good fit: Adults (≥18) undergoing PCI with the Protégé paclitaxel DCB for de novo lesions or in-stent restenosis in vessels 2.0–4.5 mm who are able to receive dual antiplatelet therapy are ideal candidates.
Not a fit: Patients who cannot provide informed consent, are allergic to paclitaxel, are unsuitable for dual antiplatelet therapy, or whose vessels fall outside the 2.0–4.5 mm range are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the registry could help clinicians determine when DCB therapy is appropriate and improve patient outcomes by clarifying safety and durability across lesion types.
How similar studies have performed: Previous studies have shown paclitaxel-coated balloons can be effective for in-stent restenosis and small-vessel disease, but broader real-world evidence across diverse coronary lesions is more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing PCI with the Protégé paclitaxel-eluting DCB * Age ≥ 18 years * Presence of a de novo lesion or in-stent restenosis in a native coronary artery or a in a bypass graft and suitable for PCI * Reference vessel diameter between 2.0 - 4.5 mm * Patient suitable for dual antiplatelet therapy (DAPT) Exclusion Criteria: * Inability to provide informed consent * Allergy to paclitaxel
Where this trial is running
Amsterdam
- Amsterdam UMC — Amsterdam, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Inge T Bosch
- Email: i.t.bosch@amsterdamumc.nl
- Phone: +31205663884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Percutaneous Coronary Intervention, Drug Coated Balloon, Paclitaxel, CAD - Coronary Artery Disease, ACS, Stable Coronary Artery Disease, Myocardial Infarction