The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent (BIOHELIX-II)
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age > or = 18 years
Willingness to comply with study follow-up requirements
Candidate for a 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)
Written informed consent
De novo or restenotic lesion in a native coronary artery; restenotic lesions must have been previously treated with only standard 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 < 100% stenosis (by operator visual estimate) with a 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
Baseline LVEF of < 30%; LVEF may be measured and assessed by standard-of-care echocardiography procedures within 90 days of the index procedure or by a left ventriculogram prior to the index procedure (operator visual assessment)
PCI in any vessel 30 days prior to the index procedure or planned for within 30 days after 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 to antiplatelet, anticoagulant or thrombolytic medications
Refusal of blood transfusions
Any other medical condition, that in the opinion of the investigator, poses an unacceptable risk for implant of a stent according to the study indications
Pregnant, planning to become pregnant or nursing during the course of the study. Women of 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 a pregnancy test.
Known allergy to L-605 CoCr alloy (cobalt, chromium, tungsten and nickel) or amorphous silicon 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 the post-market study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.
Documented diagnosis of an acute MI within 72 hours of the index procedure and an elevation of Troponin or CKMB above the URL (CKMB measurement is not required if CK is normal) at the time of the index procedure (99th percentile of the 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. ECG changes consistent with an acute MI include:
> 1 mm ST segment elevation or depression in consecutive leads
Development of pathological Q-waves in two contiguous leads of the ECG
Acute coronary syndrome with baseline Troponin > 99% URL
INR ≥ 1.6
Concomitant renal failure with serum creatinine level > 2.5 mg/dL