Outcomes after PCI using the Protégé paclitaxel drug-coated balloon.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Inge T Bosch
• Email: i.t.bosch@amsterdamumc.nl
• Phone: +31205663884

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.