Ischemic heart disease Circulatory System
Conditions
Interventions
The study will track participants forward in time from the point of stent implantation, meaning the data will be collected as events unfold during the 1-year period. Both the participants and investig
Sponsors
Kamal Encon Industries Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with age at least 18 years. 2. The patient who agrees to participate in the study by signing the EC-approved informed consent form or alternatively, the patient's legally authorized representative (LAR) agrees to the patient's participation by signing the informed consent form. 3. Suitable for implantation of one or more Everolimus Eluting Coronary Stent System in one or more native artery target lesions. 4. Patient with indication, lesion length and target lesion(s) vessel diameter according to the Indications and 'Instructions for Use' given with every Everoshine Everolimus Eluting Coronary Stent System. 5. The patient who fully agrees and are able to cooperate with clinical procedures and required follow-up. 6. The patient must agree not to participate in any other clinical study for a period of 1 year following the index procedure.
Exclusion criteria
Exclusion criteria: 1. Patient with a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB =2 times the upper limit of normal). 2. Patient with known left ventricular ejection fraction (LVEF) of 2.5 mg/dL or subject is under dialysis) 17. Platelet count 7,00,000 cells/mm3, WBC of < 3,000 cells/mm3 18. Patient requirement to implant DES other than Everolimus Stent in any of the lesions of the target vessel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of major adverse events (MACE) like cardiac death, non-cardiac death, myocardial infarction (MI) and revascularization of the target vessel measured via clinical follow-up and pre-defined outcomes at 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The rate of stent thrombosis measured via clinical follow-up and pre-defined outcomes at 30 days and 1 year 2. Cardiac death, non-cardiac death, MI, and target lesion revascularization (TLR) measured via telephonic follow-up and predefined outcomes at the 1-year follow-up | — |
Countries
India
Contacts
Public ContactAbhishek Masalawala
Outcome results
None listed