Supralimus-Core™ Pharmacokinetic (PK) Study

This is a multi-centric, interventional, non-randomized, open label, Uncontrolled, single group assignment, Pharmacokinetics study. Approximately 20 patients will be enrolled in the study. Patients will be followed for 48 days post-procedure.

Patients with de novo native coronary artery lesions located in epicardial vessel who qualify for percutaneous coronary intervention will be included according to the inclusion and exclusion criteria specified below:

Inclusion criteria

• Age ≥18 years.
• Eligible for percutaneous coronary intervention (PCI)
• Acceptable candidate for CABG
• Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris ((Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C or IIIB-C), or documented silent ischemia.
• The target lesion is a single de novo coronary artery lesion with ≥ 50% and < 100% stenosis in one of the major epicardial territories (LAD, LCX or RCA). A second target lesion in another major epicardial vessel could be treated and this second lesion should fit with the inclusion/exclusion criteria and will receive the same type of stent.
• The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.
• The target lesion must be ≤ 34 mm in length by visual estimate.
• The target reference vessel diameter must be ≥ 2.5 mm and ≤ 3.5 mm.
• Patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as notified / approved by the Institutional Review Board/Ethics Committee of the clinical site.

Exclusion criteria

• Female of childbearing potential
• Documented left ventricular ejection fraction (LVEF) ≤ 25%
• Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure
• Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®, Ceruvin) or ticlopidine (Ticlid®), heparin, sirolimus, cobalt chromium, contrast agent (that cannot be adequately pre-medicated)
• A platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3
• Acute or chronic renal dysfunction (creatinine >2.0mg/dl or >150µmol/L)
• Target vessel has evidence of thrombus
• Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment
• Previous bare metal stenting (less than 1 year) anywhere within the target vessel
• Previous drug-eluting stenting anywhere within any epicardial vessel
• The target lesion requires treatment with a device other than PTCA prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
• Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off
• Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated
• Target lesion is located in or supplied by an arterial or venous bypass graft
• Ostial target lesion
• Patient is currently participating in an investigational drug or device study, including its follow-up period
• Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind
• Within 48 days post-procedure, patient requires planned interventional treatment of any non-target vessel. Planned intervention of the target vessel after the index procedure is not allowed.
• CVA within previous 6 months
• Unprotected Left Main (LM) coronary artery disease (stenosis >50%)
• In the investigator's opinion, patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
• Planned surgery within 48 days after the index procedure
• Life expectancy less than 1 year
• Any contraindication to blood sampling