Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Dr. Saji Subramanian
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients aged 18 years and above 2.Patients undergoing PCI with implantation of the BioMime Aura. 3.Patient has given written informed consent for participation prior to enrolment 4.Patient is willing to undergo all study procedures and follow-up requirements
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, drug such as sirolimus or similar drugs or any analogue or derivative, cobalt, chromium, nickel, molybdenum, tungsten or any contrast media. 2.Patient in whom anti-platelet and/or anti-coagulant therapy are contraindicated 3.Life expectancy of less than 1 year due to non-cardiac comorbidities. 4.Pregnant or lactating females. Any condition that, in the opinion of the Investigator, would preclude safe participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion FailureTimepoint: Target Lesion Failure | — |
Secondary
| Measure | Time frame |
|---|---|
| Target Lesion Failure (TLF)Timepoint: 30 days, 6 months;Cardiovascular DeathTimepoint: 30 days, 6 months, 1 year;Target Vessel Myocardial Infarction (TV-MI)Timepoint: 30 days, 6 months, 1 year;Clinically-Driven Target Lesion Revascularization (CD-TLR)Timepoint: 30 days, 6 months, 1 year;Stent Thrombosis (ST) RateTimepoint: 30 days, 6 months, 1 year;Target Vessel Revascularization (TVR)Timepoint: 30 days, 6 months, 1 year;Target Vessel Failure (TVF)Timepoint: 30 days, 6 months, 1 year;Device SuccessTimepoint: Index procedure;Procedure SuccessTimepoint: At discharge | — |
Countries
India
Contacts
Public ContactDr Saji Subramanian
Samaritan Heart Institute
Outcome results
None listed