Trial record 7 of 3999 for:    Arteriosclerosis

The ENDEAVOR II Clinical Trial: The Medtronic Endeavor Drug Eluting Coronary Stent System in Coronary Artery Lesions

This study has been completed.
Sponsor:
Information provided by:
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00614848
First received: January 30, 2008
Last updated: April 8, 2011
Last verified: April 2011
  Purpose

To demonstrate the safety and efficacy of the Driver Coronary Stent coated with 10 mcg/mm ABT-578 compared to the uncoated Driver Stent for the treatment of single de novo lesions in native coronary arteries 2.25-3.5 mm in diameter.


Condition Intervention
Coronary Artery Disease
Arterial Occlusive Diseases
Coronary Disease
Coronary Arteriosclerosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Arteriosclerosis
Device: Endeavor drug eluting coronary stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Target Vessel Failure Rate at 9 months post procedure [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Device Success Lesion Success Procedure Success Major Cardiac Adverse Events (MACE) at 30 days and 6, 9, and 12 months, and annually thereafter out to 5 years. Late loss at 8 months as measured by QCA [ Time Frame: 30 days and 6, 9, and 12 months, and annually thereafter out to 5 years. ] [ Designated as safety issue: No ]

Enrollment: 1200
Study Start Date: June 2003
Study Completion Date: July 2009
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Endeavor Drug Eluting Coronary Stent
Device: Endeavor drug eluting coronary stent
Zotarolimus coated coronary stent (10ug/mm)
Active Comparator: 2
Driver bare-metal coronary stent
Device: Endeavor drug eluting coronary stent
Zotarolimus coated coronary stent (10ug/mm)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is an acceptable candidate for PTCA, stenting, and emergent CABG.
  • Subject must have clinical evidence of ischemic heart disease or a positive functional study.
  • Subject has single vessel disease or has multivessel disease with only moderate stenosis (max 50-60% or total occlusion (100%) for which no interventions are planned at the time of study inclusion).
  • Target lesion / vessel must meet the following criteria:

    1. Target lesion is a single de novo lesion that has not been previously treated with any interventional procedure. Only one lesion may be treated per subject
    2. Target vessel must be a native coronary artery with a stenosis of >=50% and <100%
    3. Target lesion must be >= 14 mm and ≤ 27 mm in length
    4. Target vessel reference diameter must be >= 2.25 mm and ≤3.5 mm
  • Female subjects of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
  • Subject or subject's legal representative has been informed of the nature of the study 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
  • Subject and treating physician agree that subject will comply with all required post-procedure follow-up

Exclusion Criteria:

  • A documented left ventricular ejection fraction <30%
  • A known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, cobalt, nickel, chromium, or a sensitivity to contrast media, which cannot be adequately pre-medicated
  • History of an allergic reaction or significant sensitivity or receiving drugs similar to/or synergistic to ABT-578 (rapamycin, tacrolimus, sirolimus, CCI-779 or other analogues).
  • A platelet count <100,000 cells/mm³ or >700,000 cells/mm³, or a WBC <3,000 cells/mm³
  • Evidence of an acute myocardial infarction within 72 hours of the intended treatment (defined as: Q wave or non-Q wave infarction having CK enzymes >2X the upper laboratory normal with the presence of a CK-MB elevated above the Institution's upper limit of normal).
  • Creatinine >2.0 mg/dl
  • A previous coronary interventional procedure of any kind within the 30 days prior to the procedure
  • Subject requires planned interventional treatment of either the target or any non-target vessel within 30 days post-procedure
  • Target lesion requires treatment with a device other than PTCA prior to stent placement
  • Previous stenting anywhere in the target vessel
  • Target vessel has evidence of thrombus or is excessively tortuous (2 bends >90 degrees to reach the target lesion)
  • Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off
  • Target lesion located in native vessel distally to anastomosis with vein graft or LIMA
  • Target lesion has any of the following characteristics:

    1. Lesion location is aorto-ostial, an unprotected left main lesion, or within 5mm of the origin of the LAD, LCX, or RCA
    2. Involves a side branch >2.0 mm in diameter
    3. Is at or distal to a 45º bend in the vessel
    4. Is severely calcified
  • Unprotected left main coronary artery disease (an obstruction greater than 50% in the left main coronary artery)
  • History of a stroke or transient ischemic attack within the prior 6 months
  • Active peptic ulcer or upper GI bleeding within the prior 6 months
  • The subject has a 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 or planned treatment with anti-restenotic therapies including, but not limited to, drug-eluting stents and brachytherapy
  • Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
  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: NCT00614848

Locations
France
Dr. J. Fajedet
Clinique Pasteur, France
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: J. Fajadet, MD Clinique Pasteur, France
Principal Investigator: Richard E Kuntz, MD, MSc Harvard Medical School USA
Principal Investigator: W. Wijns, MD, PhD OLV Hospital, Belgium
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Judith L. Jaeger, Director of Clinical Research, Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00614848     History of Changes
Other Study ID Numbers: IP034
Study First Received: January 30, 2008
Last Updated: April 8, 2011
Health Authority: European Union: European Medicines Agency

Keywords provided by Medtronic Vascular:
restenosis

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014