Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Poly Medicure Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Age more than 18 years 2 All Genders (Males, Females, Transgenders, Non binary) 3 Patient or legally authorized representative (LAR) agrees to participate by signing the informed consent form. 4 Patient with coronary artery disease eligible for percutaneous coronary intervention (PCI) as per regional or hospitals standard practices guidelines for PCI (For Europe as per ESC guidelines) 5 Patient with coronary artery disease having one or more de nevo or in-stent stenosis lesion in native coronary artery with a visually estimated diameter stenosis more than or equals to 70 percent 6 Patients with Reference vessel diameter of 2.0 to 4.5 mm 7 Patients with lesion length less than 48 mm
Exclusion criteria
Exclusion criteria: 1 Pregnant and lactating females 2 Candidates for emergency bypass Surgery 3 Patients corresponding to the criteria of a vulnerable population (Vulnerable subjects, including patients who are unable to fully understand all aspects of the investigation, patients who could be manipulated or unduly influenced, patients lacking capacity in the informed consent procedure and patients with dementia and cognitive impairment, patients under social security imprisonment etc) 4 Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) less than 30 Percent 5 Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel ticlopidine Everolimus or similar drugs, or any other analogue or derivative cobalt, chromium, nickel, molybdenum or contrast media 6 Current medical condition with a life expectancy of less than 12 months 7 Patient who have current unstable arrhythmias 8 Patient previously undergone CABG 9 Left Main Coronary Artery lesion 10 Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal dysfunction (serum creatinine more than 2.0 mg per dl or 150 mol per L) peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 360 days of the index procedure 11 Patients with platelet count less than 100000 cells permm3 or more than 700000 cells per mm3 or a WBC less than 3000 cells per mm3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Failure (TLF) defined as a hierarchical composite of Cardiac Death, target vessel oriented Myocardial infarction (TV-MI) and clinically indicated target lesion revascularization (Ci-TLR) at 360 days following implantation of RisoR Crest Everolimus Eluting Coronary stent.Timepoint: 360 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of TLF (Equivalent of DoCE): -Cardiovascular Death -Target vessel Myocardial infarction (TV-MI) and -Clinically indicated target lesion revascularization (Ci-TLR).Timepoint: 30, 180 and 270 days ;Incidence of POCE: -All cause death -Any stroke -Any myocardial infarction (includes non-target vessel territory) -Any revascularizationTimepoint: 30, 180, 270 and 360 days;Incidence of MACE: -Cardiovascular death -Non fatal MI -Clinically indicated Target Vessel RevascularizationTimepoint: 30, 180, 270 and 360 days;Target vessel failure (TVF)Timepoint: 30, 180, 270 and 360 days;Non -Target Vessel related Myocardial InfarctionTimepoint: 3, 30, 180, 270 and 360 days;Stent thrombosis as per -Academic Research Consortium [ARC] 2 definitions - Definite/probable -As per latency Acute, Subacute and late.Timepoint: Definite/Probable: 30, 180, 270 and 360 days Acute:0-24 hours Subacute:24 hours- 30 days late: 30-360 days;Device success: -Defined as achievement of a final residual diameter stenosis of less than 20 percent (site - reported), using the assigned device only. Successful deployment of stent with complete retrieval of delivery system without coronary dissection, device disintegration and visible malapposition and TLF.Timepoint: 0 hour, 24 hours, 3 days;procedural success: -Defined as achievement of a final diameter stenosis of Less than or equal to 20 percent (site-reported) using any PCI method, procedure success, Final myocardial perfusion greater than or equal to TIMI II, and MACE or Bleeding event free survival of the patient at DischargeTimepoint: 3 days;QCA endpoints: -In-stent and in-segment % diameter stenosis (DS) -minimum lumen diameter (MLD) -Late Lumen Loss -Angiographic binary restenosisTimepoint: 270 days;OCT endpoints: -Diameter Stenosis % -Proportions of in-stent and in-segment binary restenosis -Proportion of Struts uncovered and malapposed -Area restenosis -Neo-intimal hyperplasiaTimepoint: 270 days | — |
Countries
India, Italy
Contacts
Public ContactHaobam Rakesh Singh
Medanta-The Medicity
Outcome results
None listed