Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biotronik, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 \< 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
You may not be if
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.
For a subject to receive an investigational stent the following procedure-related criteria must not be present:
Documented diagnosis of an acute MI within 72 hours of the index procedure and an elevation of Troponin or creatine kinase-MB (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 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
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 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 is severely 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 the vessel segment either proximal or distal to the target lesion
Use of cutting balloons, atherectomy or ablative devices immediately prior to investigational stent placement
