Actively Recruiting
Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device in Patients With Coronary Artery Disease
Led by Fundación Interhospitalaria para la Investigación Cardiovascular FIC · Updated on 2026-03-03
1118
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device in Patients With Coronary Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Age 18 years or older
- Have coronary artery disease needing treatment of a coronary stenosis in a native vessel or coronary bypass graft as decided by the operator
- Treated lesions must be covered by the device extending at least 3 mm beyond both edges of the lesion or pre-dilated segment
- For multivessel disease, all treated vessels with the study device will be documented and analyzed separately
- Only one lesion per vessel will be included unless lesions are separated by 20 mm
- Lesions treated with devices other than the study device must be separated by 20 mm or considered a single treated lesion
You will not qualify if you...
- Explicit refusal to participate
- Known intolerance to sirolimus or any device component
- Contraindication to any antiplatelet therapy
- Life expectancy less than 12 months
- Need for surgical coronary revascularization
- Pregnancy or breastfeeding
- Conditions unsuitable for drug-coated balloon use, including hemorrhagic diathesis, gastrointestinal ulceration, cerebrovascular disorders restricting antiplatelet therapy, cardiogenic shock, or left ventricular ejection fraction below 30% without ventricular assist device during PCI
- Reference vessel diameter less than 2.00 mm or greater than 4.0 mm
- Treatment of the left main coronary artery
- Lesions not suitable for PCI
- Coronary artery spasm without significant stenosis
- Target lesion not suitable for drug-coated balloon-only PCI, including aorto-ostial lesions, lesions with persistent thrombus after thromboaspiration, or treatment soon after myocardial infarction with thrombus or impaired coronary flow
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain, 36312
Actively Recruiting
Research Team
V
Víctor A Jiménez Díaz, MD, MPH
CONTACT
P
Pablo Juan-Salvadores, Pharma, MPH, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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