Health Condition 1: I219- Acute myocardial infarction, unspecified
Conditions
Interventions
Intervention1: Adva Pro Sirolimus Eluting Coronary Stent System: Adva Pro is cobalt chromium Coronary Stent System mounted over rapid exchange delivery system coated with sirolimus in biodegradable po
Sponsors
Advanced MedTech Solutions Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 18 years 2. Patients that need a treatment with Adva Proââ??¢ drug eluting stent 3. Presence of one or more coronary artery stenosis in a native coronary artery or a saphenous vein graft from 2.25 to 4.50 mm in diameter that can be covered with with ADVA PRO SES. 4. No limitation on the number of treated lesions, vessels, and lesion length. 5. Able of patient or his/her authorized representative to provide informed consent to participate in this registry by signing ethics committee approved ICF (informed consent form).
Exclusion criteria
Exclusion criteria: 1. Patients needing stent not of the study device type 2. Patients needing other coronary vascular treatments next to the Adva Pro Sirolimus eluting coronary stent which can affect the device performance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac Events (MACE) at 12 months. (Major adverse cardiac events is defined as the composite of cardiac death, myocardial infarction (MI) attributed to target vessel, and any target lesion revascularization (TLR))Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Stent thrombosis (definite and probable according to ARC definitions) at 30 days, 6 and 12 months, 24 months ââ?¬Â¢ Individual components of MACE are considered at 30 days, 6 months, 12 month and 24 months as Secondary Endpoints. o Death o MI o Clinically significant restenosis (TLR) Timepoint: 1, 6, 12 and 24 months | — |
Countries
India
Contacts
Public ContactDr Pushpinder Paul
Ruby Hall Clinic
Outcome results
None listed