Qvanteq Bioactive Coronary Stent System First in Man (FIM) Clinical Investigation

This is an interventional treatment trial for Coronary Artery Disease focused on measuring CAD, PCI, bioactive coronary stent, OCT Read More

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, 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).
• The lesion must have a visually estimated diameter stenosis of ≥ 50% and < 100%
• Lesion length must be ≤16 mm
• The vessel size must be between 2.5 and 3.5 mm
• Written informed consent
• The patient agrees to the follow-up visits including angiographic follow-up and OCT control at 6 months

Key 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
• LVEF <30%
• Platelet count <100,000 cells/mm3 or >400,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
• Known renal insufficiency (Creatinine clearance less than 30 mL/Min), or subject on dialysis, or acute kidney failure
• Patient undergoing planned surgery within 6 months with the necessity to stop ASA
• Patient requiring prolonged DAPT for other diagnoses (>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 <50 years and last menstruation within the last 12 months), who did not underwent tubal ligation, ovariectomy or hysterectomy.
• Previous CABG

Angiographic Exclusion Criteria:

• 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 <3, prior to wire crossing
• The target vessel contains visible thrombus
• Restenotic lesion.