Clinical trial NCT01004575: Safety and Efficacy Study of Kaname Coronary Stent System for the Treatment of Patients With Coronary Artery Disease
Official title: Clinical Evaluation of Kaname Cobalt-Chromium Coronary Stent System in the Treatment of Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Angioplasty, Transluminal, Percutaneous Coronary
Keywords: stents
bare metal stents
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
First posted: 2009-10-30
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Current treatments for coronary artery disease include conservative treatment (drug therapies) and invasive techniques that help increase blood flow to ischemic or oxygen-deprived regions of the heart. Among the invasive techniques the most frequently used are coronary artery bypass graft surgery (CABG), and percutaneous transluminal coronary angioplasty (PTCA) without or with stents (bare metal stents (BMS) or drug eluting stents (DES)) implantation. However, all of those treatments have limitations and their effectiveness is diminished under certain circumstances. Therefore, it is essential to tailor therapy for each individual patient considering the overall patient's condition, disease severity and progression as well as concomitant diseases. The question of selection of appropriate stent for each individual patient is still unresolved and most of the physicians either follow international or national guidelines or scientific wisdom.

Although the efficacy of DES is undisputable in restenosis prevention, because some patients could have adverse outcomes from a DES, they should be used selectively in those who are most likely to benefit, and in that decision process several important issues should be addressed such as:Patients' adherence to post-stenting therapy, Bleeding risk, Need for elective surgery, Risk for restenosis, Risk for stent thrombosis. It is still believed that many patients will do well with BMSs and that this technology requires further refinements to improve outcome. For the above reasons Terumo has designed the new coronary BMS, Kaname™, a balloon expandable Cobalt-Chromium (CoCr) stent pre-mounted onto a high pressure, semi-compliant balloon on a rapid exchange delivery catheter. The Kaname stent is the subject of the current prospective, multi-centre KARE study.

Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from Target vessel failure TVF
timeFrame: 6 months post-procedure
Secondary outcomes:
measure: Freedom from TVF for patients treated with ≥ 3 mm stents.
timeFrame: 6 months post-procedure
measure: Freedom from TVF for patients treated with 2.5 and 2.75 mm stents
timeFrame: 6 months post-procedure
measure: Freedom from TVF
timeFrame: 30 days,12 months and 3 and 5 years post-procedure
measure: Clinically driven target lesion revascularization (TLR) free rate .
timeFrame: 30 days, 6 and 12 months, 3 and 5 years post-procedure
measure: Clinically driven target vessel revascularization (TVR) free rate.
timeFrame: 30 days, 6 and 12 months, 3 and 5 years post-procedure
measure: Device success
timeFrame: Baseline procedure
measure: Lesion success
timeFrame: Baseline procedure
measure: Procedure success
timeFrame: During baseline hospital stay
measure: Angiographic in-stent acute gain
timeFrame: Baseline procedure
measure: Angiographic in-stent and in-segment binary restenosis rate (≥ 50%) diameter stenosis
timeFrame: 6 months post-procedure
measure: Angiographic in-stent, in-segment, proximal, and distal minimum lumen diameter (MLD)
timeFrame: 6 months post-procedure
measure: In-stent late-loss
timeFrame: 6 months post-procedure
measure: % Diameter Stenosis, in-stent and in-segment .
timeFrame: 6 months post-procedure
measure: Neointimal hyperplasia volume as measured by intravascular ultrasound.
timeFrame: 6 months post-procedure
measure: Major adverse cardiac events (MACEs) rate .
timeFrame: 30 days, 6 and 12 months, 3 and 5 years post-procedure
measure: Serious adverse event rate .
timeFrame: 30 days, 6 and 12 months, 3 and 5 years post-procedure
measure: Device failure .
timeFrame: Baseline procedure
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Cardiovasculaire et Pneumologie Louis Pradel
city: Nantes
country: France
facility: CHU NORD
city: Nimes
country: France
facility: Clinique les Franciscaines
city: Paris CEDEX 05
country: France
facility: Hopital d'Instructions des Armées du Val de Grace
city: Toulouse CEDEX 9
country: France
facility: CHU Rangeuil
city: Fulda
country: Germany
facility: Klinikum Fulda gAG
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
city: Mainz
country: Germany
facility: Klinikum des Johannes Gutenberg Universität
city: Florence
country: Italy
facility: Ospedale Careggi
city: Milan
country: Italy
facility: Policlinico Milano
city: Palermo
country: Italy
facility: Ospedale Civico Palermo
city: Belgrade
country: Serbia
facility: Clinical Centre of serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zemun
city: Belgrade
country: Serbia
facility: Institute for Cardiovascular Disease Dedinje
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital La Paz
city: Vigo
country: Spain
facility: Hospital Meixoeiro
Study officials:
affiliation: CHU Rangeuil, 31059 Toulouse, France
name: Didier Carrie, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: