Health Condition 1: null- Patients with Coronary Artery Disorder
Conditions
Interventions
Intervention1: PRISTINE-Everolimus Eluting Coronary Stent System: PRISTINE stents are implanted in coronary arteries of patients meet all inclusion and exclusion criteria
Intervention2: Everolimus Elu
Sponsors
Relisys Medical Devices LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or non-pregnant female 2.Have chest pain consistent with angina pectoris or a history of documented myocardial infarction or documented silent ischemia or hemodynamically significant stenosis in the opinion of the investigator 3. Target vessel 2.75mm-3.5mm in diameter (visual estimate) 4. Target lesion length 13mm to 20mm (visual estimate) 5. At least TIMI grade II coronary flow 6. Patient is willing to come back for a follow-up evaluations including repeat coronary angiogram after 8 months (in 50 patients) 7. Patient must provide written informed consent prior to the index procedure using a form that is approved by the Ethics Committee
Exclusion criteria
Exclusion criteria: 1.Patient has experienced an acute myocardial infarction within 72 hours prior to the index procedure 2.Unprotected left main coronary disease 3.Significant stenosis proximal or distal to the target lesion that might require revascularization 4.Ostial location of the target lesion 5.Angiographic evidence of thrombus within the target lesion 6.Documented LVEF 7.Totally occluded vessel 8.Patients with heart failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiac event (MACE Target Lesion Failure (TLF) In-stent angiographic binary restenosis In-stent late loss In-segment late loss Timepoint: 30 days, 90 days, 180 days, 240 days and 365 days | — |
Secondary
| Measure | Time frame |
|---|---|
| In-stent late loss In-segment late lossTimepoint: 240 days | — |
Countries
India
Contacts
Public ContactS Prashanth
CARE Hospital
Outcome results
None listed