BIOHELIX-I Bare Metal Stent Study

Inclusion Criteria: For a subject to be enrolled in the study and considered for the index procedure, thefollowing 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 functionalischemia study (e.g. exercise treadmill test, thallium stress test, SPECT, stressechocardiogram or cardiac CT) Stable angina pectoris is defined as a documentedCanadian Cardiovascular Society Classification of I, II, III or IV Unstable anginapectoris 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 criteriamust be met:

• De novo or restenotic lesion in a native coronary artery; restenotic lesions must havebeen previously treated with only standard percutaneous transluminal coronaryangioplasty (PTCA) (treatment must be > 12 months prior to the index procedure)

• Target lesion must be in a major coronary artery (target vessel). The target vesselincludes the entire territory of the left anterior descending artery, left circumflexartery 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 thenon-target lesion occurring first using commercially available therapy (with exceptionof brachytherapy).

• Lesions may be one solid lesion or a series of multiple, smaller lesions to be treatedas one lesion

• Target lesion must be treatable with a single investigational stent; an additionalstent may be used when treating a vessel dissection or another similar intra-procedurecomplication (use of investigational stent preferred)

• Angiographic evidence of ≥ 50% and < 100% stenosis (by operator visual estimate) witha TIMI flow > 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, thefollowing initial exclusion criteria must not be present:

• Baseline LVEF of < 30%; LVEF may be measured and assessed by standard-of-careechocardiography procedures within 90 days of the index procedure or by a leftventriculogram prior to the index procedure (operator visual assessment).

• PCI in any vessel 30 days prior to the index procedure or planned for within 30 daysafter the index procedure

• Stroke or transient ischemic attack within the last 6 months prior to enrollment

• Intolerance to contrast agents that cannot be medically managed and/or intolerance toantiplatelet, anticoagulant or thrombolytic medications

• Refusal of blood transfusions

• Any other medical condition, that in the opinion of the investigator, poses anunacceptable risk for implant of a stent according to the study indications

• Pregnant, planning to become pregnant or nursing during the course of the study. Womenof child-bearing potential must have a negative blood pregnancy (beta hCG) test.Female subjects who are surgically sterile or post-menopausal are exempt from having apregnancy test.

• Known allergy to L-605 CoCr alloy (cobalt, chromium, tungsten and nickel) or amorphoussilicon carbide

• Life expectancy of less than one year

• Participation in any other clinical investigational device or drug study.

• Subjects may be concurrently enrolled in a post-market study, as long as thepost-market study device, drug or protocol does not interfere with the investigationaltreatment or protocol of this study. For a subject to receive an investigational stent the following procedure-related criteriamust not be present:

• Documented diagnosis of an acute MI within 72 hours of the index procedure and anelevation of Troponin or creatine kinase-MB (CKMB) above the URL (CKMB measurement isnot required if CK is normal) at the time of the index procedure (99th percentile ofthe individual investigative site's normal reference population)

• For subjects with stable angina and elevated Troponin, CKMB <99% URL is required

• ECG changes consistent with an acute MI within 72 hours of the index procedure. ECGchanges consistent with an acute MI include:

> 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 < 3,000 / µL), thrombocytopenia (platelet count < 100,000 / µL) or thrombocytosis (platelet count > 700,000 / µL)

• Unprotected left main coronary artery disease (CAD) (> 50% diameter stenosis byoperator visual estimate)

• Target vessel has been treated with any PCI procedure (e.g. PTCA, stent, cuttingballoon, atherectomy, etc.) within 12 months prior to the index procedure

• Target lesion has been treated with a stent, cutting balloon or atherectomy any timeprior to the index procedure or has been treated with PTCA within 12 months prior tothe 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 treatmentduring 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 theleft 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 arteryand involves a side branch with a diameter > 2 mm (by operator visual estimate)

• Presence of a complication following pre-dilatation of target lesion

• Presence of a complication following treatment of a non-target lesion (if applicable)

• Presence of a target vessel/lesion that has excessive tortuousity/angulation or isseverely calcified preventing complete inflation of an angioplasty balloon

• Angiographic evidence of thrombus within the target lesion

• Target lesion is located within an aneurysm or associated with an aneurysm in thevessel segment either proximal or distal to the target lesion

• Use of cutting balloons, atherectomy or ablative devices immediately prior toinvestigational stent placement