Health Condition 1: I748- Embolism and thrombosis of other arteries
Conditions
Interventions
Intervention1: NIL: NIL
Intervention2: NIL: NIL
Control Intervention1: NIL: NIL
Control Intervention2: NIL: NIL
Sponsors
Meril Life Sciences Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.The participant must be aged 18 years or older, irrespective of gender. 2. Participant diagnosed with coronary artery disease (CAD)requiring revascularization, such as stable angina, unstable angina, acute myocardial infarction (STEMI or NSTEMI),silent ischemia with evidence of significant coronary artery disease. 3. Participants with single or multiple coronary artery lesions are eligible for stenting. 4. Participant with De novo coronary artery lesions. 5. The participant must be willing and able to provide written Informed Consentby signing and dating the IRB or ECapproved Informed Consent form. 6. The participant is willing and able to comply with postoperative scheduled clinical evaluations.
Exclusion criteria
Exclusion criteria: 1.Participants have any known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drug such as Sirolimus (Rapamycin) or similar drugs or any analogue or derivative, cobalt, chromium, nickel, molybdenum, tungsten or any contrast media. 2.Life expectancy of less then 1 year will be excluded. 3. Pregnant women will be excluded. Participants on anti-coagulant or anti-platelet therapy. 4.Participants known to have a lesion that prevents complete inflation of an angioplasty balloon. 5.Transplant participants. 6. Participant with active gastrointestinal bleeding or history of gastrointestinal bleeding within the past 6 months. 7. The participant is not willing and able to comply with postoperative scheduled clinical evaluations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Target Lesion Failure 2. Major Adverse Cardiac Events 3. Device SuccessTimepoint: 1. 1 week , 1 month, 3 months, 6 months , 1 year 2. Through Discharge, 7 days , 30 days , 3 months , 6 months , 1 Year 3. Intra operative 3. Device Success | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Target Vessel Revascularization 2. Stent Thrombosis 3. Procedural Success 4.Adverse Events 5. Lenght of Hospital Stay 6. Target Vessel Failure 7. Enzyme MeasurementsTimepoint: 1. 1 month, 3 months , 6 months , 1 year 2. 3 months , 6 months , 1 year 3. post operative , Discharge 4. Through Discharge, 1 week , 1 month, 3 months ,6 months , 1 year 5. admission to Discharge 6. 1 month, 3 months , 6 months , 1 year 7. 1 month , 3 months , 6 months , 1 year | — |
Countries
India
Contacts
Public ContactDr KiranKumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed