Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Nano Therapeutics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patient who is 18 years and above 2.Patients undergoing percutaneous coronary intervention with Encruso RAL-Everolimus Eluting Coronary Stent System 3.Patient or legal guardian understands the study requirements and provides written informed consent 4.Patient who is on dual antiplatelet therapy for at least 6 months post procedure
Exclusion criteria
Exclusion criteria: 1.Patient has known hypersensitivity or allergies to Aspirin, Heparin,Clopidogrel, Ticlopidine, Everolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, or contrast media 2.Patient with life expectancy less than 2 years 3.Pregnant and lactating females or planning to become pregnant while in the study 4.Patient currently participating in another investigational drug or device clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Failure (TLF) rate A composite endpoint of Cardiac Death Target Vessel related Myocardial Infarction (MI) and Clinically driven Target Lesion Revascularization (TLR) at 1 year follow-up OCT sub study: Strut-level analysis Proportion of covered struts o Thickness of neointimal hyperplasia (NIH) over covered struts Proportion of malapposed struts Mean malapposed strut to lumen distance Ratio of uncovered struts to total struts Maximum length of consecutive segments of uncovered and malapposed struts Cross-section level analysis: NIH area, volume Percent volumetric stent obstruction Incomplete stent apposition (ISA) area and volumeTimepoint: 1 year OCT sub study: 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| OCT SUB STUDY: Angiographic Endpoint: In-stent and in-segment acute gain post procedure Diameter stenosis percent at post procedure and 6 months In-stent area late loss (LL) at 6 months In-segment late loss at 6 months In-stent area and in-segment area % diameter stenosis post procedure and at 6-months In-stent area and in-segment angiographic binary restenosis rate at 6-months Aneurysm, thrombus and persisting dissection at 6 monthsTimepoint: 6 month;OCT SUB STUDY: Mean and minimum lumen area and volume Stent expansion, eccentricity and symmetry Mean and minimum lumen area and volume ISA area and volume Proportion of malapposed struts, mean malapposed strut-to-lumen distanceTimepoint: post procedure;OCT SUB STUDY: Serial changes in mean lumen area, minimum lumen area, and ISA area from post procedure to 6 months Proportion of cross sections with peri strut low intensity areas (PLIA) and neoatherosclerosis Quantification of NIH backscattering, attenuation and optical intensityTimepoint: 6 months;Procedural endpoints: Device success (residual coronary stenosis less than 50 %, normal coronary flow and absence of coronary dissection) Device success and absence of PCI complication (periprocedural MI, coronary perforation, urgent CABG or death) or revascularization within 3 daysTimepoint: 3 days;Target Vessel Failure (TVF) rate ID-TVR ID-TLR TV-MI Patient oriented composite endpoint (a composite endpoint of all cause death, all myocardial infarction, and all revascularization) Major Adverse Cardiac Events (MACE) which is the composite endpoint of cardiac death,non-fatal myocardial infarction and non-fatal stroke Nonfatal MI Cardiac death (death from cardiac cause) All cause death (including cardiac & non cardiac death) Stent thrombosis (defined by Academic Research Consortium [ARC] criteria)Timepoint: 2 year | — |
Countries
India
Contacts
Public ContactPriyadarshini Arambam
Batra Hospital and Medical Research Centre
Outcome results
None listed