closing of heart arteries after stenting Coronary artery stenosis
Conditions
Interventions
All patients will be treated with the NanoTM Polymer-free Sirolimus Coronary
Stent System.
Sponsors
Lepu Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) 18 to 85 years; 2) Evidence of myocardial ischemia without raised troponin (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study); 3) The patient has a planned intervention of up to two de novo lesions, in different epicardial vessels; 4) Lesion(s) must have a visually estimated diameter stenosis of >=50% and
Exclusion criteria
Exclusion criteria: 1) Evidence of ongoing acute myocardial infarction in ECG prior to procedure; 2) LVEF 700,000 cells/mm3, a WBC of 2.5 mg/dL, or subject on dialysis); 5) History of bleeding diathesis or coagulopathy; 6) The patient is a recipient of a heart transplant; 7) Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel prasugrel, ticagrelor and ticlopidine), sirolimus or stainless steel; 8) Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy; 9) Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is: in-stent neointimal hyperplasia volume obstruction (%) at 3 months follow-up by OCT assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| OCT endpoints (as assessed by a central Core Laboratory): • Neointimal hyperplasia area/volume at 3 months follow-up; • Mean/Minimal Stent diameter/area/volume at 3 months follow-up; • Mean/Minimal Lumen diameter/area/volume at 3 months follow-up; • Mean/maximal thickness of the struts coverage at 3 month • Percentage number of covered struts at 3 months • Incomplete strut apposition at 3 months For those patients that did not achieve the optimal/ successful OCT criteria at 3 months an additional OCT investigation will be planned at 6 months follow-up where these same endpoints will be assessed. Angiographic endpoints: • MLD and %DS post procedure and at 3 months • Late Lumen Loss at 3 months; • Binary Restenosis (DS >=50%) at 3 months • All measurements will be made of the in-stent, in-segment, proximal and distal stent margins. Clinical endpoints: • Acute success (device and procedural success); • Device-oriented Composite Endpoints at 3, 4 and 5 months and annually to 2 years and its individual components. (Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization) • Stent thrombosis according to the ARC definitions at 3, 4 and 5 months and annually to 2 years • Other Adverse Device Effects | — |
Countries
Netherlands
Outcome results
None listed