Vascular Implant Safety and Efficacy Study

Study Overview
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Brief Summary
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Assessment of the safety and clinical performance of a coronary stent system in de novo coronary artery lesions

Official Title
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Vascular Implant Safety and Efficacy Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is > 18 years and < 85 years old Written subject informed consent Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients Subject is eligible for percutaneous coronary intervention (PCI) Subject is acceptable candidate for coronary artery bypass surgery Subject is eligible for Dual Anti Platelet Therapy (DAPT) Subjects with a maximum of two single discrete de novo lesions in two separate native coronary arteries that can be treated with the study stent during the index procedure Reference vessel diameter of 3.0 mm to 3.8 mm by visual estimation. Target lesion length up to 22 mm by visual estimation. Target lesion with ≥ 50% and < 100% stenosis by visual estimation Exclusion Criteria: Left main coronary artery disease Three-vessel coronary artery disease at the time of index procedure Angiographic evidence of thrombus in target vessel Chronic total occlusion Heavily calcified or extremely tortuous lesions that would prevent complete inflation of a pre-dilatation balloon Bifurcation lesion requiring side branch intervention, if side branches > 2mm in diameter are involved Ostial lesions (within 5 mm of vessel origin) In-stent restenosis Lesions with prior treatment with a drug coated balloon (DCB) Target lesion is located in or supplied by an arterial or venous bypass graft Target lesion requires treatment with. rotational atherectomy Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography Previous treatment of target vessel within 9 months of index-procedure Patients with cardiogenic shock Documented left ventricular ejection fraction (LVEF) ≤ 30% Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention) Hemodynamically unstable NSTEMI or STEMI within 72 hours prior to index procedure Cerebrovascular event (within 3 months of index procedure) Subject is receiving oral or intravenous immuno-suppressive therapy (inhaled steroids are allowed) or has known life-limiting immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus, but not diabetes mellitus) Known allergies to: Acetylsalicylic Acid (ASA), heparin, contrast medium, sirolimus, or similar drugs, exipients or the stent material Triple anticoagulation therapy Life expectancy less than 1 year Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study Inability to understand or read the informed consent form Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet In the investigators opinion subjects will not be able to comply with the follow-up requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: consecutive enrolment of cohort 1 (primary endpoint at 1 month), and cohort 2 (primary endpoint at 9 months)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 and 2<br> | Device: Stent<br>* Implantation of coronary stent in de novo coronary artery lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strut coverage cohort 1 | Strut coverage will be assessed by OCT analysis | 1 month | 
| In stent late lumen loss cohort 2 | Late lumen loss with will be assessed by central QCA assessment | 9 months |