Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Advanced MedTech Solutions Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Greater than 18 years. 2. All (Males, Females, Transgenders, Non-binary). 3. Patient or legally authorized representative (LAR) agrees to participation by signing the informed consent form. 4. Patient with coronary artery disease Eligible for percutaneous coronary intervention (PCI). 5. Patient with coronary artery disease having one or more de novo stenosis lesion in two native coronary artery with a visually estimated diameter stenosis greater than or equal 70 percent. 6. Patients with Reference vessel diameter of 2.5 to 3.50 mm. 7. Patients with lesion length less than or equal 36 mm.
Exclusion criteria
Exclusion criteria: 1 Ethical- Pregnant and lactating females 2 Condition- Patients requiring staged procedure 3 Condition- Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) less than 30 percent 4 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 5 Condition- Current medical condition with a life expectancy of less than 12 months 6 Condition- Diagnosis: Acute Myocardial Infarction within 72 hours of Planned Index procedure 7 Condition- Patient has current unstable arrhythmias 8 Procedural- Patients previously treated with PCI or CABG for any coronary artery lesion revascularization 9 Procedural- Patients with Chronic Total Occlusion in two or more vessels 10 Procedural- Patients with Ostial lesions (within 5mm of vessel origin). 11 Procedural- Patients with Bifurcation lesions that include a side branch greater than 2 mm diameter 12 Procedural- Unprotected Left Main Coronary Artery lesion 13 Condition- Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist 14 Condition- Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal function (serum creatinine greater than 2 mg per dl or 150 µmol per L), peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 1 year of the index procedure 15 Condition- Patients with platelet count less than 100 cells per mm3 or greater than 700 cells per mm3 or a WBC less than 3 cells per mm3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Endpoint MACE (Hierarchical incidence of Cardiovascular Death, Myocardial infarction or Target Vessel Revascularization)Timepoint: 1 Year | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of DOCE Cardiovascular Death Myocardial infarction in the territory of Target vessel Clinically driven target lesion revascularizationTimepoint: 30 Days, 180 Days, 270 Days & 360 days;Incidence of POCE All cause death Any Stroke Any myocardial infarction Any revascularizationTimepoint: 30 Days, 180 Days, 270 Days & 360 days;Incidence of MACE Cardiovascular Death Non-fatal MI Target Vessel RevascularizationTimepoint: 30 Days, 180 Days & 360 days;Target vessel failure (TVF)Timepoint: 30 Days, 180 Days, 270 Days and 360 days;Non-Target Vessel related Myocardial InfarctionTimepoint: 30 Days, 180 Days, 270 Days and 360 days;Stent thrombosis Stent thrombosis as per Academic Research Consortium [ARC] Evidence definitions â?? Definite & probable As per latency - Acute (0-24 hours), Subacute (24 hours-30 days) & late (30-365 days)Timepoint: 0-24 hours, 24 hours-30 days & late 30-365 days;Procedural Success Residual Stenosis less than 20 percent Successful reperfusion of Target vessel region with TIMI Flow greater than or equal 2Timepoint: During & after the procedure;Acute Device Success Acute Device Success as defined by Residual Stenosis less than or equal 20 percentTimepoint: During and after the procedure;For QCA Group Late Lumen Loss Angiographic binary restenosis In-stent & in-segment minimum lumen diameter (MLD) & percent diameter stenosis (DS)Timepoint: 270 Days;Device success Residual coronary stenosis less than 20 percent Normal coronary flow & absence of coronary dissections greater than C Procedural & absence of PCI complications including periprocedural MI, coronaryperforation, urgent CABG or death or revascularization within 3 days of Index procedureTimepoint: 0 hour, 24 hours, 3 days | — |
Countries
France, India
Contacts
Public ContactPriyadarshini Arambam
Advanced MedTech Solutions Private Limited
Outcome results
None listed