Trials / Recruiting

RecruitingNCT07444957

Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device in Patients With Coronary Artery Disease

Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device (SeQuent® Sirolimus-Coated Balloon) in Patients With Coronary Artery Disease: A Prospective Observational Study

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 1,118 (estimated)

Sponsor: Fundación Interhospitalaria para la Investigación Cardiovascular FIC · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This prospective, multicenter, post-market observational study aims to evaluate the safety and effectiveness of the crystalline sirolimus-coated balloon (SeQuent® Sirolimus-Coated Balloon) for the treatment of coronary artery disease in routine clinical practice. Consecutive, unselected adult patients undergoing percutaneous coronary intervention for de novo coronary lesions or in-stent restenosis will be enrolled. The primary objective is to assess target lesion failure at 12 months, defined as the composite of target vessel myocardial infarction or ischemia-driven target lesion revascularization. Secondary objectives include angiographic procedural success, major adverse cardiovascular events, bleeding outcomes, and longer-term clinical results up to 36 months, as well as outcomes across predefined anatomical and clinical subgroups. The study seeks to answer whether treatment with the crystalline sirolimus-coated balloon provides a safe and effective revascularization strategy in a real-world population with diverse clinical presentations and lesion characteristics.

Conditions

Timeline

Start date: 2026-01-05
Primary completion: 2027-07-05
Completion: 2030-07-06
First posted: 2026-03-03
Last updated: 2026-03-03

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07444957. Inclusion in this directory is not an endorsement.