Angina Pectoris
Conditions
Brief summary
A prospective, single-arm, multi-centre, observational, real world registry to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions.
Detailed description
Title: A prospective, single-arm, multi-centre, observational, real world registry to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions. Short Title: Morpheus - Global Registry Sponsor: Meril Life Sciences Pvt. Ltd Device Used:BioMime™ Morph Sirolimus Eluting Coronary Stent System Study population: The utilization of the BioMime™ Morph Sirolimus Eluting Coronary Stent System implantation in very long (length ≤ 56 mm) coronary lesions in native coronary arteries with reference vessel diameter of 2.25 mm to 3.50 mm. Enrolment:Minimum 400 patients will be enrolled Clinical Sites:Minimum 15 sites Objectives:Purpose of this Registry is to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System in very long (length ≤ 56 mm) coronary lesions in native coronary arteries with reference vessel diameter of 2.25 mm to 3.50 mm. Study Design:This is a prospective, single-arm, multi-centre, observational, real world registry. All patients will be followed for up to 24 months. Primary Outcome Measures:Freedom of target lesion failure (TLF) at 6 month and up to 24 month TLF is defined as a composite of cardiac death, myocardial infarction and target lesion revascularization. Secondary Outcome Measures: 1. MACE at 1, 6, 12 and 24 month Defined as a composite of cardiac death, myocardial infarction attributed to the target vessel or Ischemia-driven TLR . 2. Target vessel failure at 1, 6, 12 and 24 month Defined as cardiac death, myocardial infarction attributed to the target vessel, or target vessel revascularization. 3. Academic Research Consortium (ARC) defined stent thrombosis at 1, 6, 12 and 24 months. Definite, probable and possible stent thrombosis during acute, subacute, late and very late phase. Other Outcome Measures: 1. Procedure Success: It is defined as angiographic evidence of \<30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MACE prior to hospital discharge (for subjects with more than one lesion stented, the worse case is counted) 2. Device Success: It is defined as angiographic evidence of \<30% final residual stenosis of the target lesion using only the assigned device
Interventions
DEVICESirolimus Eluting Coronary Stent System
Patient with Angina Pectoris will be enrolled for the intervention
Sponsors
Meril Life Sciences Pvt. Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient must be at least 18 years of age. 2. Significant native coronary artery stenosis (\> 50% by visual estimate) with lesion length of ≤56mm. 3. The patient or guardian agrees to the protocol requirements and the schedule of follow-up and provides informed written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site -
Exclusion criteria
1. Patients contraindicated to any of the following medications: aspirin, heparin, clopidogrel, cobalt-chromium, contrast agents and sirolimus. 2. An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrolment. 3. Patients who are actively participating in another drug or device investigational study. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom of target lesion failure | TLF at 6 month | composite of cardiac death, myocardial infarction and target lesion revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 1, 6, 12 and 24 month | composite of cardiac death, myocardial infarction attributed to the target vessel or Ischemia-driven TLR. |
| Target vessel failure | 1, 6, 12 and 24 month | cardiac death, myocardial infarction attributed to the target vessel, or target vessel revascularization. |
| Academic Research Consortium (ARC) defined stent thrombosis | 1, 6, 12 and 24 month | Definite, probable and possible stent thrombosis during acute, subacute, late and very late phase. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | Before Discharge | Angiographic evidence of \<30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MACE prior to hospital discharge (for subjects with more than one lesion stented, the worse case is counted) |
| Device Success | Before Discharge | Angiographic evidence of \<30% final residual stenosis of the target lesion using only the assigned device |
Countries
Hungary, Jordan, Malaysia, Netherlands
Contacts
Primary ContactAshok Thakkar, Ph.D
Backup ContactKartik Vyas, M.Sc.
Outcome results
None listed