Coronary Artery Disease Clinical Trial
— KAREOfficial title:
Clinical Evaluation of Kaname Cobalt-Chromium Coronary Stent System in the Treatment of Patients With Coronary Artery Disease
NCT number | NCT01004575 |
Other study ID # | T111E4 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2009 |
Est. completion date | June 30, 2016 |
Verified date | October 2019 |
Source | Terumo Europe N.V. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess whether the new Kaname coronary stent is safe and effective for the treatment of patients with coronary artery disease.
Status | Completed |
Enrollment | 282 |
Est. completion date | June 30, 2016 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient is = 18 years old. - Patient is eligible for PCI and acceptable candidate for CABG. - Clinical evidence of ischemic heart disease and/or a positive functional study. Documented stable angina pectoris (CCS 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia. - The target lesion or target vessel meets all the following criteria;a) is a single de novo lesion or restenotic post-PTCA (non-stented) lesion in one native coronary artery.b)The stenosis of target lesion is = 50% and < 100% c)The target lesion length must be = 25 mm d)The target reference vessel diameter must be suitable for treatment with stents between 2.5 and 4.0 mm long - Patient has been informed of the nature of the study, understands the study requirements and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site. - The patient is able to comply with all specified follow-up evaluations. Exclusion Criteria: - Most recent LVEF of the patient is < 25%. - Known allergies to the following: aspirin, Clopidogrel bisulfate, Prasugrel or Ticlopidine, heparin, cobalt, chromium, nickel, or contrast agent (that cannot be adequately premedicated). - A platelet count <100,000 cells/mm3 or >700,000 cells/mm3. - WBC count < 3500 cells/mm3. - Evidence of MI with positive Troponin within 72 hours of the intended treatment. - Previous PCI (<30 days) anywhere within the target vessel. - Planned interventional treatment of any non-target vessel <30 days post-procedure will be required. Planned intervention on the target vessel or on a significant lesion of > 50% stenosis anywhere within the target vessel after the index procedure will be required. - The target lesion requires treatment with a device other than PTCA balloon prior to stent placement. (e.g. but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.). - Previous stenting anywhere within the target vessel. - Target vessel has evidence of thrombus. - Excessive tortuousity (> 60°) of the target vessel proximal to the target lesion (visual estimate). - Either of the following characteristics in the target lesion (visual estimate): a)Ostial target lesion or bifurcation lesion b)Target lesion involves a side branch > 2mm in diameter c) Target lesion has excessive tortuousity (> 45°)d)Moderate to severely calcified lesion which can not be successfully predilated e)Target lesion is located in or supplied by an arterial or venous bypass graft f)Significant (> 40%) stenosis proximal or distal to the target lesion. g) A complete occlusion (TIMI flow 0 or 1). - Target lesion located in left main trunk. - Stroke or transient ischemic attack < prior 180 days. - Active peptic ulcer or upper GI bleeding < prior 180 days. - The patient has bleeding hemorrhagic diathesis or coagulopathy. The patient will refuse a blood transfusion. - The patient has a widespread peripheral vascular disease. - Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl). - The patient requires multiple stent implantations for a tandem lesion. - Life expectancy < 1 year. - Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials. - In the investigators opinion patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study. - Patient is in cardiogenic shock. - Female of child-bearing potential. |
Country | Name | City | State |
---|---|---|---|
France | Hopital Cardiovasculaire et Pneumologie Louis Pradel | Lyon | |
France | CHU NORD | Nantes | |
France | Clinique les Franciscaines | Nimes | |
France | Hopital d'Instructions des Armées du Val de Grace | Paris CEDEX 05 | |
France | CHU Rangeuil | Toulouse CEDEX 9 | |
Germany | Klinikum Fulda gAG | Fulda | |
Germany | Klinikum Ludwigshafen | Ludwigshafen | |
Germany | Klinikum des Johannes Gutenberg Universität | Mainz | |
Italy | Ospedale Careggi | Florence | |
Italy | Policlinico Milano | Milan | |
Italy | Ospedale Civico Palermo | Palermo | |
Serbia | Clinical Centre of serbia | Belgrade | |
Serbia | Clinical Hospital Center Zemun | Belgrade | |
Serbia | Institute for Cardiovascular Disease Dedinje | Belgrade | |
Spain | Hospital Clinico San Carlos | Madrid | |
Spain | Hospital La Paz | Madrid | |
Spain | Hospital Meixoeiro | Vigo |
Lead Sponsor | Collaborator |
---|---|
Terumo Europe N.V. |
France, Germany, Italy, Serbia, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Freedom from Target vessel failure TVF | Freedom from Target vessel failure TVF defined as composite of clinically driven target vessel revascularization (TVR)myocardial infarction or cardiac death that could not be clearly attributed to a vessel other than the target vessel. | 6 months post-procedure | |
Secondary | Freedom from TVF for patients treated with = 3 mm stents. | Freedom from Target Vessel Failure (composite of clinically driven TVR, myocardial infarction or cardiac death that could not be clearly attributed to a vessel other than the target vessel) for patients treated with = 3 mm stents. | 6 months post-procedure | |
Secondary | Freedom from TVF for patients treated with 2.5 and 2.75 mm stents | Freedom from Target Vessel Failure (composite of clinically driven TVR, myocardial infarction or cardiac death that could not be clearly attributed to a vessel other than the target vessel) for patients treated with 2.5 and 2.75 mm stents | 6 months post-procedure | |
Secondary | Freedom from TVF | Freedom from Target Vessel Failure (composite of clinically driven TVR, myocardial infarction or cardiac death that could not be clearly attributed to a vessel other than the target vessel) | 30 days,12 months and 3 and 5 years post-procedure | |
Secondary | Clinically driven target lesion revascularization (TLR) free rate . | Clinically driven target lesion revascularization (TLR) free rate | 30 days, 6 and 12 months, 3 and 5 years post-procedure | |
Secondary | Clinically driven target vessel revascularization (TVR) free rate. | Clinically driven target vessel revascularization (TVR) free rate. | 30 days, 6 and 12 months, 3 and 5 years post-procedure | |
Secondary | Device success | Device success defined as achievement of a residual diameter stenosis of < 50% by QCA or < 30% by visual estimate, using the assigned device only. | Baseline procedure | |
Secondary | Lesion success | Lesion success defined as the attainment of residual diameter stenosis of < 50% by QCA or < 30% by visual estimate, using any percutaneous method. | Baseline procedure | |
Secondary | Procedure success | Procedure success defined as achievement of a final diameter stenosis of < 50% by QCA or < 30% by visual estimate, using any percutaneous method, without MACE (composite of cardiac death, MI and TLR) . | During baseline hospital stay | |
Secondary | Angiographic in-stent acute gain | Angiographic in-stent acute gain at the end of the procedure | Baseline procedure | |
Secondary | Angiographic in-stent and in-segment binary restenosis rate (= 50%) diameter stenosis | Angiographic in-stent and in-segment binary restenosis rate (= 50%) diameter stenosis | 6 months post-procedure | |
Secondary | Angiographic in-stent, in-segment, proximal, and distal minimum lumen diameter (MLD) | Angiographic in-stent, in-segment, proximal, and distal minimum lumen diameter (MLD) | 6 months post-procedure | |
Secondary | In-stent late-loss | In-stent late-loss (as measured by QCA) defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up MLD. | 6 months post-procedure | |
Secondary | % Diameter Stenosis, in-stent and in-segment . | % Diameter Stenosis, in-stent and in-segment. | 6 months post-procedure | |
Secondary | Neointimal hyperplasia volume as measured by intravascular ultrasound. | Neointimal hyperplasia volume as measured by intravascular ultrasound at 6 months post-procedure | 6 months post-procedure | |
Secondary | Major adverse cardiac events (MACEs) rate . | Major adverse cardiac events (MACEs: composite of cardiac death,, myocardial infarction and TLR) rate. | 30 days, 6 and 12 months, 3 and 5 years post-procedure | |
Secondary | Serious adverse event rate . | Serious adverse event rate. | 30 days, 6 and 12 months, 3 and 5 years post-procedure | |
Secondary | Device failure . | Any device failure | Baseline procedure |
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