Health Condition 1: I22- Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Health Condition 2: I22- Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Conditions
Interventions
Intervention1: Dr Yash Paul Sharma: Professor HOD
Intervention2: SAVIOUR STENT: Brand Name: Saviour
Classification of Device: Class III (As per EU MDR)6 and Class-D (As per Indian MDR-2017)7
Shelf Lif
Sponsors
Ace Cardiopathy Solutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patient who can provide informed consent form in writing to provide date for the study. Patient that need a treatment with drug eluting stent.
Exclusion criteria
Exclusion criteria: Prior stenting in target or non target vessel within 90 days before index procedure patient participating in other study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device Oriented Composite endpoints at 1 year post index procedure 1 Cardiac Death 2 Target Vessel related Myocardial Infarction (TV-MI) and 3 Clinically driven Target Lesion Revascularization (TLR) Timepoint: Clinical endpoints measured at 1 month 6 months and 1 year post index procedure 1 Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, any stroke and any revascularization. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine any undesirable side effects under normal conditions of use and assess whether the risks constitute weighed against the intended performance of the Drug Eluting coronary Stent System. To evaluate the performance of SAVIOUR- Drug Eluting Coronary Stent System.Timepoint: One Year | — |
Countries
India
Contacts
Public ContactMr Anoop Sharma
ACE Cardiopathy Solution Pvt Ltd
Outcome results
None listed