The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent (BIOHELIX-II)
- Conditions
- coronary artery dieasecoronary lesions10011082
- Registration Number
- NL-OMON39866
- Lead Sponsor
- Biotronik
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
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 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 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.
• 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
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 < 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
• Intolerance to contrast agents that cannot be medically managed and/or intolerance to antiplatelet, anticoagulant or thrombolytic medications
• 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:
• Concomitant renal failure with serum creatinine level > 2.5 mg/dL
• Unprotected left main CAD (> 50% diameter stenosis by operator visual estimate)
• 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 and is <15 mm apart from target lesion
• 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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In-stent late lumen loss at 9 months.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Event rates will be estimated for the following endpoints at 1, 9 and 12 months<br /><br>post-index procedure unless otherwise noted:<br /><br>• Target vessel failure (TVF) rate<br /><br>• Individual components of the TVF rate (cardiac death, myocardial infarction<br /><br>(MI), ischemia-driven target vessel revascularization (TVR))<br /><br>• Overall TVR rate<br /><br>• TLF rate, including individual components of the target lesion failure (TLF)<br /><br>rate (cardiac death, myocardial infarction, ischemia-driven TLR)<br /><br>• Overall TLR rate<br /><br>• Rate of all cause mortality and all cause MI, including individual components<br /><br>• Stent thrombosis rate<br /><br>• Procedure success<br /><br>• Device success<br /><br>• Lesion success<br /><br>• Angina pectoris classification<br /><br>• Rates for individual adverse events</p><br>