Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:34 AM
Study NCT ID:
NCT07444957
Status:
RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device in Patients With Coronary Artery Disease
Sponsor:
Fundación Interhospitalaria para la Investigación Cardiovascular FIC
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SECuRE
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: