A retrospective, single-center, observational study to assess the safety and performance of BioMime Morph Sirolimus Eluting Coronary Stent System in patients with symptomatic ischemic heart disease.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Target Lesion Failure (TLF): Defined as the composite of cardiovascular death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR)
Study Overview
Brief Summary
Data to be collected between 1st January 2021 and 31st December 2022.
Cardiovascular disease is a leading cause of global mortality, with coronary heart disease posing a significant burden. While DES has revolutionized interventional cardiology, concerns like late stent thrombosis have driven ongoing DES advancements. A single long-tapered BioMime Morph SES system is often enough for treating long diffused lesion in tapered arteries, and therefore, the local arterial walls can be saved from over-exposure to drug/metal and its related adverse events such as delayed healing, peri-procedural MI, risk of target lesion revascularization and very late ST, which are caused due to use of multiple stents. The BioMimeâ„¢ Morph Sirolimus Eluting Coronary Stent System represents a new generation of DES, featuring a unique stent morphology, advanced sirolimus-eluting technology, and biocompatible polymer coatings. Therefore, this study aims to assess the clinical safety and performance of the BioMimeâ„¢ Morph Sirolimus Eluting Coronary Stent System.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with symptomatic ischemic heart disease who were implanted with BioMimeâ„¢ Morph SES System between 1st January 2021 and 31st December 2022.
Exclusion Criteria
- •As this is a retrospective study, there are no formal exclusion criteria for the study.
Outcomes
Primary Outcomes
Target Lesion Failure (TLF): Defined as the composite of cardiovascular death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR)
Time Frame: 1 Year
Secondary Outcomes
- 1. Cardiovascular death [Time Frame: Through 1 year](2. Target Vessel Myocardial Infarction (TV-MI) [Time Frame: Through 1 year])
Investigators
Dr Satish Suryavanshi
SMC Heart Institute and IVF Research Centre