Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Multimedics LLP
Eligibility
Inclusion criteria
Inclusion criteria: Adult Subjects with ischemic heart disease due to coronary artery lesion Subjects implanted with Sirolimus Eluting Coronary Stent from the manufacturer via Percutaneous Transluminal Coronary Angioplasty (PTCA)
Exclusion criteria
Exclusion criteria: - Subjects expect in those with known allergies - Subjects who are indicated for coronary bypass surgery. - Subjects who exhibit angiographic evidence of existing thrombus. - Subjects allergic to L605 Chromium cobalt. - Subjects with a contradiction for anti-platelet / anti-coagulant therapy, this includes patients who have had major surgery, an obstetrical delivery organ biopsy, or puncture of a non- compressible vessel within 14 day of this procedure. - Subjects with a history of gastrointestinal bleeding, recent C.V.A., diabetic hemorrhagic retinopathy, or any condition compromised by prolonged anti-coagulant. - Subjects who have experienced a recent (less than 1 week) acute myocardial infarction. - Subjects with diffuse disease, defined as long segments of abnormal vessel without interposed normal vessel. - Subjects who have transplants. - Subjects who got implanted with any other manufacturer Sirolimus Eluting Coronary Stent System
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate clinical safety of the Sirolimus Eluting Coronary Stent System and to observe any undesirable events under normal condition of use.Timepoint: 3-4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate the performance of Sirolimus Eluting Coronary Stent SystemTimepoint: 3-4 months | — |
Countries
India
Contacts
Public ContactDr Kishore K S
Sagar Hospitals-DSI,Banashankari
Outcome results
None listed