Safety and Efficacy Study of Kaname Coronary Stent System for the Treatment of Patients With Coronary Artery Disease (KARE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Terumo Europe N.V.
ClinicalTrials.gov Identifier:
NCT01004575
First received: October 29, 2009
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Angioplasty, Transluminal, Percutaneous Coronary
Device: Kaname cobalt-chromium coronary stent
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Kaname Cobalt-Chromium Coronary Stent System in the Treatment of Patients With Coronary Artery Disease

Further study details as provided by Terumo Europe N.V.:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Freedom from TVF for patients treated with ≥ 3 mm stents. [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: Yes ]
  • Freedom from TVF for patients treated with 2.5 and 2.75 mm stents [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: Yes ]
  • Freedom from TVF [ Time Frame: 30 days,12 months and 3 and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • Clinically driven target lesion revascularization (TLR) free rate . [ Time Frame: 30 days, 6 and 12 months, 3 and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • Clinically driven target vessel revascularization (TVR) free rate. [ Time Frame: 30 days, 6 and 12 months, 3 and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • Device success defined as achievement of a residual diameter stenosis of < 50% by QCA or < 30% by visual estimate, using the assigned device only. [ Time Frame: Baseline procedure ] [ Designated as safety issue: No ]
  • Lesion success defined as the attainment of residual diameter stenosis of < 50% by QCA or < 30% by visual estimate, using any percutaneous method. [ Time Frame: Baseline procedure ] [ Designated as safety issue: No ]
  • 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) . [ Time Frame: During baseline hospital stay ] [ Designated as safety issue: Yes ]
  • Angiographic in-stent acute gain [ Time Frame: Baseline procedure ] [ Designated as safety issue: No ]
  • Angiographic in-stent and in-segment binary restenosis rate (≥ 50%) diameter stenosis [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
  • Angiographic in-stent, in-segment, proximal, and distal minimum lumen diameter (MLD) [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
  • % Diameter Stenosis, in-stent and in-segment . [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
  • Neointimal hyperplasia volume as measured by intravascular ultrasound. [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
  • Major adverse cardiac events (MACEs) rate . [ Time Frame: 30 days, 6 and 12 months, 3 and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • Serious adverse event rate . [ Time Frame: 30 days, 6 and 12 months, 3 and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • Any device failure . [ Time Frame: Baseline procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 280
Study Start Date: October 2009
Estimated Study Completion Date: August 2015
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kaname
patients treated with Kaname stent
Device: Kaname cobalt-chromium coronary stent
implantation of Kaname Cobalt-Chromium coronary stent
Other Names:
  • Kaname
  • Cobalt-chromium
  • coronary stent

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004575

Locations
France
Hopital Cardiovasculaire et Pneumologie Louis Pradel
Lyon, France, 69677
CHU NORD
Nantes, France, 44035
Clinique les Franciscaines
Nimes, France, 30000
Hopital d'Instructions des Armées du Val de Grace
Paris CEDEX 05, France, 75230
CHU Rangeuil
Toulouse CEDEX 9, France, 31059
Germany
Klinikum Fulda gAG
Fulda, Germany, 36043
Klinikum Ludwigshafen
Ludwigshafen, Germany, 67063
Klinikum des Johannes Gutenberg Universität
Mainz, Germany, 55131
Italy
Ospedale Careggi
Florence, Italy, 50141
Policlinico Milano
Milan, Italy, 20122
Ospedale Civico Palermo
Palermo, Italy, 90100
Serbia
Institute for Cardiovascular Disease Dedinje
Belgrade, Serbia, 11040
Clinical Hospital Center Zemun
Belgrade, Serbia, 11000
Clinical Centre of serbia
Belgrade, Serbia, 11000
Spain
Hospital La Paz
Madrid, Spain, 28046
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Meixoeiro
Vigo, Spain, 36214
Sponsors and Collaborators
Terumo Europe N.V.
Investigators
Principal Investigator: Didier Carrie, Prof Dr CHU Rangeuil, 31059 Toulouse, France
  More Information

No publications provided

Responsible Party: Terumo Europe N.V.
ClinicalTrials.gov Identifier: NCT01004575     History of Changes
Other Study ID Numbers: T111E4
Study First Received: October 29, 2009
Last Updated: July 18, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
France: French Data Protection Authority
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Italy: Ethics Committee
Serbia: Ethics Committee
Italy: Ministry of Health
Spain: Ethics Committee
Spain: Ministry of Health

Keywords provided by Terumo Europe N.V.:
stents
bare metal stents

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Chromium
Cobalt
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on October 20, 2014