MedTrace Logo

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

NCT07444957 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1118

Last updated 2026-03-03

No results posted yet for this study

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

  • Coronary Arterial Disease (CAD)
  • NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)
  • Stable Angina, Unstable Angina, NSTEMI
  • Drug Coated Balloon
  • ST-Elevation Myocardial Infarction
  • Silent Ischemia

Sponsors & Collaborators

  • Fundación Interhospitalaria para la Investigación Cardiovascular FIC

    lead OTHER

Principal Investigators

  • Víctor A Jiménez Díaz, MD, MPH · Hospital Álvaro Cunqueiro, Vigo. SERGAS

  • Pablo Juan-Salvadores, Pharma, MPH, PhD · Galicia Sur Health Research Institute (IIS Galicia Sur), Cardiovascular Research Group, Vigo, Spain.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2027-07-05
Completion
2030-07-06

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07444957 on ClinicalTrials.gov