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

NCT01004575 | Completed DMC

• 1 other identifier: T111E4
• Study Type: interventional
• Target: 282
• Locations: 5 countries
• Sites: 17

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.

Conditions

Coronary Artery Disease; Angioplasty, Transluminal, Percutaneous Coronary

Keywords

stents; bare metal stents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Freedom from TVF for patients treated with ≥ 3 mm stents.

  6 months post-procedure

• Freedom from TVF for patients treated with 2.5 and 2.75 mm stents

  6 months post-procedure

• Freedom from TVF

  30 days,12 months and 3 and 5 years post-procedure

• Clinically driven target lesion revascularization (TLR) free rate .

  30 days, 6 and 12 months, 3 and 5 years post-procedure

• Clinically driven target vessel revascularization (TVR) free rate.

  30 days, 6 and 12 months, 3 and 5 years post-procedure

Study Arms (1)

Kaname

EXPERIMENTAL

patients that are treated by implanting Kaname Cobalt-Chromium coronary stent

Device: implantation of Kaname Cobalt-Chromium coronary stent

Interventions

implantation of Kaname Cobalt-Chromium coronary stent DEVICE

implantation of Kaname Cobalt-Chromium coronary stent

Also known as: Kaname, Cobalt-chromium, coronary stent

Kaname

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Terumo Europe N.V.: lead

Study Sites (17)

Hopital Cardiovasculaire et Pneumologie Louis Pradel

Lyon, 69677, France

Location

CHU NORD

Nantes, 44035, France

Location

Clinique les Franciscaines

Nîmes, 30000, France

Location

Hopital d'Instructions des Armées du Val de Grace

Paris, 75230, France

Location

CHU Rangeuil

Toulouse, 31059, France

Location

Klinikum Fulda gAG

Fulda, 36043, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen, 67063, Germany

Location

Klinikum des Johannes Gutenberg Universität

Mainz, 55131, Germany

Location

Ospedale Careggi

Florence, 50141, Italy

Location

Policlinico Milano

Milan, 20122, Italy

Location

Ospedale Civico Palermo

Palermo, 90100, Italy

Location

Clinical Centre of serbia

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Zemun

Belgrade, 11000, Serbia

Location

Institute for Cardiovascular Disease Dedinje

Belgrade, 11040, Serbia

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Hospital Meixoeiro

Vigo, 36214, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Didier Carrie, Prof Dr

  CHU Rangeuil, 31059 Toulouse, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: October 30, 2009
• Study Start: October 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: June 30, 2016
• Last Updated: October 8, 2019

Record last verified: 2019-10

Locations

SE (3); ES (3); FR (5); IT (3); DE (3)