A Prospective, Multinational Investigation of the Supralimus® Sirolimus-Eluting Stent for the Treatment of Unselected Patients With Coronary Lesions in the "Real- World" Clinical Practice
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 1,274
- Locations
- 7
- Primary Endpoint
- MAJOR ADVERSE CARDIAC EVENTS (MACE)
Study Overview
Brief Summary
E-SERIES Registry evaluate the procedural and clinical outcomes of the Supralimus® SES in the treatment of unselected, high risk patients having coronary Artery blockage in the real world clinical practice.
Detailed Description
E-SERIES Registry is Prospective, multinational (Asia, South America and Europe), non-randomized, post-marketing web-based registry.
For this Study Up to 100 clinical sites in Asia, South America and Europe. Patients "ALL COMERS" assigned for percutaneous coronary interventions who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with the Supralimus® SES.
All subjects who provided signed informed consent prior to procedure, and have at least one lesion in a major epicardial vessel or major branch (>2.25mm), and are suitable for percutaneous treatment including stenting procedure with the Supralimus® SES. There are no limit regarding the number of lesions and/or study stents to be used, and stenting technique will be left at the operator's discretion; however, it is recommended according to the BEST interventional practice according to the current guidelines.
All patients will undergo follow-up clinical evaluation at 1, 6, 12 and 24 months. Angiographic follow-up will be performed at 6 months in a subset of high risk lesions including bifurcations (first 100 lesions) and left main stem (first 100 lesions).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •CLINICAL INCLUSION CRITERIA: Patients >18 years, clinical indication for elective or emergency percutaneous coronary intervention with stent implantation of at least one angiographically documented coronary artery lesion; agreement to undergo ALL study protocol follow-ups.
- •ANGIOGRAPHIC INCLUSION CRITERIA: Diseased coronary vessels with at least one lesion with ≥50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (>2.25mm) with anatomy suitable for percutaneous treatment with the Supralimus SES.
Exclusion Criteria
- •CLINICAL EXCLUSION CRITERIA: Known illness with life expectancy <12 months; impossibility to comply with all protocol follow-ups.
- •ANGIOGRAPHIC EXCLUSION CRITERIA: Anatomy unsuitable for percutaneous treatment with implantation of the Supralimus SES.
Arms & Interventions
Supralimus® Sirolimus-Eluting Coronary Stent
Intervention: Supralimus® Sirolimus-Eluting Coronary Stent (Device)
Outcomes
Primary Outcomes
MAJOR ADVERSE CARDIAC EVENTS (MACE)
Time Frame: 12 months
Secondary Outcomes
- Rates of procedural success(24 month)
- Rates of Major Adverse Cardiac Event (MACE)(In-hospital, 30 days, 6 and 24 months)
- Rates of target lesion revascularization (TLR)(6 and 12 months)
- Rates of stent thrombosis (acute, sub-acute, late and very-late)(Up to 24 months follow-up)