Coronary artery disease coronary artery stenosis
Conditions
Interventions
Axetis Inert Stent
Sponsors
Axetis AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: *18 to 85 years *Evidence of myocardial ischemia without elevated Troponin / cardiac biomarkers (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study). NSTEMI patients are allowed, as long as Troponin is within the normal limits before the start of the procedure. *The patient has a planned intervention of up to two de-novo lesions in two different vessels (previously untreated vessels) *Lesion must have a visually estimated diameter stenosis of *50% and
Exclusion criteria
Exclusion criteria: - Evidence of ongoing acute myocardial infarction in ECG and or elevated cardiac biomarkers prior to procedure - LVEF 400,000 cells/mm3, a WBC of 2.5 mg/dL, or subject on dialysis) - History of bleeding diathesis or coagulopathy - The patient is a recipient of a heart transplant - Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel, ticagrelor and ticlopidine) or stainless steel - 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 - Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives *Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter *Target lesion in left main stem. *Target lesion involves a side branch > 2.0mm in diameter *Aorto-ostial target lesion (within 3 mm of the aorta junction). *Total occlusion or TIMI flow 1, prior to wire crossing *The target vessel contains visible thrombus *Restenotic lesion *Located within an arterial or saphenous vein graft *Target vessel with previously placed stent or with graft *Treatment of more than 1 lesion in one vessel, or treatment of more than two lesions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is in-stent Late Lumen Loss (LLL) at 6 months after stent implantation as assessed by off-line QCA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Angiographic endpoints: * Acute Lumen Gain (mm); * MLD (mm) post procedure and at 6 months; * Diameter Stenosis (%) post procedure and at 6 months; * Binary Restenosis (DS *50%) at 6 months All measurements will be made of the in-stent, in-segment, proximal and distal stent margins OCT endpoints Quantitative assessment at baseline * prolapse area/volume Quantitative assessment (at baseline and at 6 months follow-up): * Mean/Minimal Lumen diameter/area/volume * Mean/Minimal Stent diameter/area/volume * Incomplete strut apposition Quantitative assessment (at 6 months follow-up): * In-stent neointimal hyperplasia volume obstruction (%) * Neointimal hyperplasia area/volume * Mean/maximal thickness of the struts coverage * Percentage number of covered struts Quantitative and Qualitative assessment: * Residual edge dissections * Thrombus (intraluminal mass) Clinical endpoints: * Acute success (device and procedural success) * Device-oriented Composite Endpoints at 6 months and 12 months (Device-oriented Composite Endpoint (DoCE) is defined as Cardiac Death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated TargetLesionRevascularization) and its individual components. * Stent thrombosis according to the ARC definitions up to 12 months follow-up. | — |
Countries
Netherlands
Outcome results
None listed