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A prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to that of the commercially available Resolute IntegrityTM Drug-Eluting Stent.
The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, never previously treated coronary artery lesions
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Inclusion criteria
General Inclusion Criteria
Angiographic Inclusion Criteria
Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries;
If a non-target lesion is treated, it must be treated first and only with commercially available PTCA balloons and/or stents. Post PCI of the non-target vessel, all of the following conditions must be met:
Reference vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter by visual estimate;
Target lesion < 20 mm in length by visual estimate (the intention is to cover the entire lesion with one stent of adequate length); and
Target lesion stenosis ≥ 50% and < 100% by visual estimate.
Exclusion criteria
General Exclusion Criteria
Patient is currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials;
The patient requires a staged procedure of the target vessel within 6-months or a staged procedure of a non-target vessel within 30-days post-procedure;
The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.);
Any DES deployment anywhere in the target vessel within the past 9-months;
Any BMS deployment anywhere in the target vessel within the past 6-months;
Any previous stent placement within 10 mm (proximal or distal) of the target lesion;
Myocardial infarction within 72-hours of the index procedure, with the exception of:
Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial;
Concurrent medical condition with a life expectancy of less than 12-months;
Documented left ventricular ejection fraction (LVEF) ≤ 30%;
Unstable angina pectoris from an extra-cardiac cause (Braunwald Class A I-III);
Known allergies to the following: Acetylsalicylic acid (ASA), Clopidogrel bisulfate, Ticlopidine, Prasugrel, Rapamycin, Zotarolimus, PEAIII AcBz, Heparin/ Bivalirudin, or contrast agent (that cannot be adequately premedicated);
Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3.000 cells/mm3 or hemoglobin < 100g/l;
Acute or chronic renal dysfunction (serum creatinine > 170μmol/L);
History of a stroke or transient ischemic attack (TIA) within the prior 6-months;
Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6-months;
History of bleeding diathesis or coagulopathy or will refuse blood transfusions; and
Patients requiring ongoing anticoagulation with warfarin or dabigatran.
Angiographic Exclusion Criteria
Primary purpose
Allocation
Interventional model
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159 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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