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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 14

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 <100%
• Lesion length must be <=16 mm
• Vessel size must be between 2.5 mm 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

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) <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, 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary Angiographic endpoint is in-stent Late Lumen Loss (LLL) at 6 months<br /><br>after stent implantation as assessed by off-line QCA.<br /><br><br /><br>The primary OCT endpoint is mean neointimal thickness as assessed by OCT at 6<br /><br>months by off-line OCT analysis.</p><br>

Secondary Outcome Measures

Name	Time	Method

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