myocardial ischemia and coronary atherosclerosis
Conditions
Interventions
The patient has a planned intervention of one single de novo lesion in one or
two separate major epicardial territories (LAD, LCX, or RCA).
Sponsors
QVANTEQ
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Subjects must be at least 18 years of age • Evidence of myocardial ischemia without elevated cardiac biomarkers (e.g. stable or unstable angina with stable haemodynamic condition, or silent ischemia demonstrated by positive territorial functional study) • The patient has a planned intervention of one single de novo lesion in one or two separate major epicardial territories (LAD, LCX, or RCA) • Lesion must have a visually estimated diameter stenosis of >=50% and
Exclusion criteria
Exclusion criteria: • Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure. • Patient suffered from stroke/TIA or myocardial infarction during the last 6 months • Left ventricle ejection fraction (LVEF) 400,000 cells/mm3, a WBC of 1 month) • History of bleeding diathesis or coagulopathy • Patient requiring oral anticoagulation (Coumadin, NOAC) • The patient is a recipient of a heart transplant • Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel or cobalt-chromium • 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 • Female of child bearing potential (age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary Angiographic endpoint is in-stent Late Lumen Loss (LLL) at 6 months after stent implantation as assessed by off-line QCA. The primary OCT endpoint is mean neointimal thickness as assessed by OCT at 6 months by off-line OCT analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Angiographic endpoints: • Acute Lumen Gain (mm); • In-segment Late Lumen Loss (LLL) at 6 months; • 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 • Stent symmetry • Stent expansion • 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 • Percentage of incomplete apposed struts • Healing Score Quantitative and Qualitative assessment: • Residual edge dissections • Thrombus (intraluminal mass) Clinical endpoints: • Acute success (device and procedural success) • Device-oriented Composite Endpoints at 1, 6 and 12 months 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). • Death at all timepoints • Myocardial infarction (Q-wave, Non q-wave) at all timepoints • Revascularization of the target vessel, clinically indicated at all timepoints • Any revascularization at all timepoints • Stent thrombosis according to the ARC definitions up to 12 months follow-up. | — |
Countries
Netherlands
Outcome results
None listed