Observing Heart Artery Outcomes After Drug-Coated Balloon Treatment

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The registry follows adults who are having a coronary stent procedure (PCI) with the Protégé paclitaxel-coated balloon, for a new narrowing or a narrowing inside an old stent.

Age

18 years or older

Sex

All sexes can join

Disease stage

A new narrowing (de novo lesion) or a re-narrowing inside a stent (in-stent restenosis), in a native heart artery or a bypass graft. The vessel is 2.0 - 4.5 mm wide.

Earlier treatment

The person must be able to take dual antiplatelet therapy (DAPT, two blood-thinning medicines).

Main reasons for not taking part

• Cannot give informed consent
• Allergy to paclitaxel

The registry criteria, word for word

What the trial wants to find out

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.