Advapro Coronary Stent System in Coronary Artery Diseased Patients.
Status: Not yet recruiting

A Prospective, Multicentre, Pilot Study to Evaluate the Safety and Performance of the AdvaPro Sirolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian and European Population.

To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months.

Of the 120, 40 patients will be assigned to European population and 80 patients will be assigned to Indian population. QCA is applicable for only in sub-strategy participants at baseline and 9 month follow-up visit.

A QCA Analysis will be performed on minimum 48 patients in Indian population only.

Interval(Days) for patients visit at Day 0, Day 30±6, Day 180±8, Day 270±10 and Day 360±14.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age >18 years Gender : All (Males, Females, Transgenders, Non-binary) ICF : Patient or legally authorized representative (LAR) agrees to participation by signing the informed consent form. Condition - Clinical : Patient with coronary artery disease Eligible for percutaneous coronary intervention (PCI) Condition - Angiographic : Patient with coronary artery disease having one or more de novo stenosis lesion in two native coronary artery with a visually estimated diameter stenosis ≥70% Condition - Angiographic : Patients with Reference vessel diameter of 2.5 ~ 3.50 mm Condition - Angiographic : Patients with lesion length ≤ 36 mm  Exclusion Criteria:  Ethical : Pregnant and lactating females Patients requiring staged procedure Condition : Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) <30% Condition : Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media Condition : Current medical condition with a life expectancy of less than 12 months Condition : Diagnosis: Acute Myocardial Infarction within 72 hours of Planned Index procedure Condition : Patient has current unstable arrhythmias Procedural : Patients previously treated with PCI or CABG for any coronary artery lesion revascularization Procedural : Patients with Chronic Total Occlusion in two or more vessels Procedural : Patients with Ostial lesions (within 5.0mm of vessel origin). Procedural : Patients with Bifurcation lesions that include a side branch >2.0 mm diameter Procedural : Unprotected Left Main Coronary Artery lesion Condition : Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist Condition : Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal function (serum creatinine >2.0mg/dl or 150 µmol/L), peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 1 year of the index procedure Condition : Patients with platelet count <100.000 cells/mm3 or >700.000 cells/mm3 or a WBC <3.000 cells/mm3 - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult