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To investigate the safety and efficacy of the Cinatra™ Corolimus Drug Eluting Stent for the treatment of de novo lesions in native coronary arteries.
Full description
This is a single-arm, multicentre pilot study designed to provide an indication of the effectiveness and safety of the Cinatra™ Corolimus Eluting Coronary Stent System. The primary endpoint to be evaluated in this study is late lumen loss (in-stent) at 6 months post-procedure as measured by QCA in the 30 participants undergoing angiography at this timepoint. Late lumen loss is defined as the difference between the post-index procedure minimal lumen diameter (MLD) and the follow-up MLD.
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Inclusion criteria
Angiographic:
Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries
If a non-target lesion is treated, it must be treated first and only with commercially available PTCA balloons and/or stents. Post PCI of the non-target vessel, all of the following conditions must be met:
Target lesion must be a de novo lesion in native coronary artery
Target lesion must be ≤ 22 mm in length
Target lesion must have a stenosis of ≥ 50% and < 100%
Target vessel must have a reference vessel diameter (RVD) appropriate for treatment with a of 3.0mm or3.5 mm stent
Target vessel must have a Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 2
Exclusion criteria
Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, chromium, stent coatings (i.e. fatty acids, glycerides, and alpha tocopherol), or a sensitivity to contrast media, which cannot be adequately pre-medicated
History of an allergic reaction or significant sensitivity to drugs such as , zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
Platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³ within 7 days prior to index procedure
Serum creatinine level 170 micromol/L within 7 days prior to index procedure
Evidence of an acute myocardial infarction (MI) within 72 hours of the intended trial procedure (defined as: Q wave myocardial infarction (QWMI) or non-Q wave myocardial infarction (NQWMI) having CK enzymes > 2X the laboratory upper limit of normal with the presence of an elevated CK-MB (any amount above the laboratory upper limit of normal)
Previous PCI of the target vessel within 9 months prior to the procedure
Any planned additional PCI procedure within 30 days post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure
During the index procedure, the target and/or non-target lesion(s) requires treatment with a device other than PTCA prior to stent placement (including, but not limited to, cutting balloon, atherectomy, thrombectomy, etc.)
Left ventricular ejection fraction (LVEF) < 30% if evaluated, or clinical evidence of significant congestive heart failure (NYHA Class III or IV) within the prior 30 days
History of a stroke or transient ischemic attack (TIA) within the prior 6 months
Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
History of bleeding diathesis or coagulopathy or will refuse blood transfusions
Concurrent medical condition with a life expectancy of less than 12 months
Any previous treatment of the target vessel(s) for restenosis, including brachytherapy
Any condition which, in the Investigator's opinion, may interfere with the subject's optimal participation in the study 17. Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures
Angiographic:
Target lesion is located in native vessel distal to anastomosis with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass with more than 40% diameter stenosis anywhere within the graft
Previous stenting in the target vessel.
The target vessel has other lesions with greater than 40% diameter stenosis based on visual estimate or on-line QCA
The target vessel has evidence of thrombus
The target vessel is excessively tortuous (two bends > 90º to reach the target lesion)
The target lesion has any of the following characteristics:
Unprotected left main coronary artery disease (an obstruction greater than 50% in the left main coronary artery)
Primary purpose
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Interventional model
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31 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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