BIOHELIX-I Bare Metal Stent Study

Inclusion Criteria

For a subject to be enrolled in the study and considered for the index procedure, the following initial inclusion criteria must be met:

• Age ≥ 18 years
• Willingness to comply with study follow-up requirements
• Candidate for a percutaneous coronary intervention (PCI) procedure
• Candidate for coronary artery bypass graft surgery
• Documented evidence of stable or unstable angina pectoris or positive functional ischemia study (e.g. exercise treadmill test, thallium stress test, SPECT, stress echocardiogram or cardiac CT) Stable angina pectoris is defined as a documented Canadian Cardiovascular Society Classification of I, II, III or IV Unstable angina pectoris is defined as a documented Braunwald Classification of B & C, I, II, III
• Written informed consent

For a subject to receive an investigational stent, the following procedure-related criteria must be met:

• De novo or restenotic lesion in a native coronary artery; restenotic lesions must have been previously treated with only standard percutaneous transluminal coronary angioplasty (PTCA) (treatment must be > 12 months prior to the index procedure)
• Target lesion must be in a major coronary artery (target vessel). The target vessel includes the entire territory of the left anterior descending artery, left circumflex artery or right coronary artery and any major side branch of the artery.
• A maximum of one target lesion and one non-target lesion may be treated per subject. The lesions must be located in separate coronary arteries, with treatment of the non-target lesion occurring first using commercially available therapy (with exception of brachytherapy).
• Lesions may be one solid lesion or a series of multiple, smaller lesions to be treated as one lesion
• Target lesion must be treatable with a single investigational stent; an additional stent may be used when treating a vessel dissection or another similar intra-procedure complication (use of investigational stent preferred)
• Angiographic evidence of ≥ 50% and 1
• Target lesion length of ≤ 31 mm by operator visual estimate
• Target vessel reference diameter of 2.25 mm to 4.0 mm by operator visual estimate

Exclusion Criteria

For a subject to be enrolled in the study and considered for the index procedure, the following initial exclusion criteria must not be present:

• Baseline LVEF of 1 mm ST segment elevation or depression in consecutive leads New left bundle branch block (LBBB) Development of pathological Q-waves in two contiguous leads of the electrocardiogram (ECG)
• Acute coronary syndrome with baseline Troponin > 99% URL
• INR ≥ 1.6
• Concomitant renal failure with serum creatinine level > 2.5 mg/dL
• Unresolved neutropenia (white blood cell count 700,000 / µL)
• Unprotected left main coronary artery disease (CAD) (> 50% diameter stenosis by operator visual estimate)
• Target vessel has been treated with any PCI procedure (e.g. PTCA, stent, cutting balloon, atherectomy, etc.) within 12 months prior to the index procedure
• Target lesion has been treated with a stent, cutting balloon or atherectomy any time prior to the index procedure or has been treated with PTCA within 12 months prior to the index procedure
• Target vessel treated with brachytherapy anytime prior to index procedure
• Planned PCI in the target vessel within 9 months after the index procedure
• Target vessel has a non-target lesion with a > 50% stenosis that requires treatment during the index procedure
• Lesions preventing distal perfusion (TIMI flow 0 and 1) prior to wire crossing
• Target lesion is in the left main coronary artery or within 2 mm of the origin of the left anterior descending artery or left circumflex artery by operator visual estimate
• Target lesion is located within a saphenous vein graft or arterial graft
• Target lesion involves a bifurcation - lesion is located in a major coronary artery and involves a side branch with a diameter > 2 mm (by operator visual estimate)
• Presence of a complicat