Health Condition 1: I249- Acute ischemic heart disease, unspecified
Conditions
Interventions
Intervention1: Not applicable. Study is observational.: Not applicable. Study is observational.
Control Intervention1: Not Applicable. Study is observational.: Not Applicable. Study is observational.
Sponsors
Purple MicroPort Cardiovascular Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients with minimum age of 18 years. Patients implanted with study device and the hospital stay to a maximum of first seven days post index procedure. Patients or Legally Acceptable Representative (LAR)/Impartial Witness understand study requirements and willing to provide written informed consent and willing to comply to study requirements.
Exclusion criteria
Exclusion criteria: Patient with known hypersensitivity or idiosyncratic reaction to a) Sirolimus or its derivatives. b) Antiplatelet/anticoagulant drugs. c) L605 CrCo alloy. d) Biodegradable polymers Poly(L-Lactide), 50:50 Poly (D,L-lactide-co glycolide). Patient with terminal illness with life expectancy less than 1 year. Patient with history of Cardiovascular Accident (CVA) within last 3 months. Patient with history of diabetic haemorrhagenic retinopathy. Patients with coronary stents implanted less than one calendar year ago. Patients with previous coronary stents implanted in the targeted lesion(s). Patient Implanted with other then the study devices DES or BMS. Patients who are not willing to visit the same study site for 5-years of the follow-up period as per the study requirements. Women of childbearing potential. Any significant medical condition which in the Investigatorâ??s opinion may interfere with the patientâ??s optimal participation in the study such as an active infection or peptic ulcer or upper GI bleeding. Currently participating in another investigational drug or another device study, or subject to inclusion in another investigational drug or another device study during follow up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Major Adverse Cardiac Events (MACE) as composite of cardiac-death, myocardial infarction (MI), target lesion revascularization (TLR) and target vessel revascularization (TVR), in the 1-, 6- and 12-month clinical follow-up of post implantation index procedure â?¢ Patient Oriented Composite Endpoint (PoCE) (primary) - defined as the composite of all cause death, any MI (Non target vessel), any stroke, Stent Thrombosis (ST), Stent Restenosis, Non-TLR, Non TVR, Target Lesion Failure (TLF) at 1-, 6- and 12-months clinical follow-up of post implantation index procedureTimepoint: 1, 6, 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Major Adverse Cardiac Events (MACE) as composite of cardiac-death, Myocardial Infarction (MI), Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR), at intervals of 24, 36, 48 and 60- months of post implantation index procedure â?¢ PoCE (secondary) - defined as the composite of all-cause death, any MI (Non-target vessel), any stroke, Stent Thrombosis (ST), Stent Restenosis, Non-TLR, Non TVR, Target Lesion Failure (TLF) at intervals of 24, 36, 48 and 60-months of post implantation index procedureTimepoint: 24, 36, 48 and 60 months. | — |
Countries
India
Contacts
Public ContactPratyesh Somani
Clinexel Life Sciences Pvt. Ltd.
Outcome results
None listed