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Coronary Artery DiseaseENDEAVOR IINCT00614848

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

A study testing Endeavor drug eluting coronary stent in people with Coronary Artery Disease and Arterial Occlusive Diseases, run by Medtronic Vascular at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Endeavor drug eluting coronary stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteFrance
Study dates
Jun 2003to Jul 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
  • Target vessel must be a native coronary artery with a stenosis of >=50% and <100%
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  • Target lesion must be >= 14 mm and ≤ 27 mm in length
  • 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

Who cannot join

  • 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
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  • 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:
  • Lesion location is aorto-ostial, an unprotected left main lesion, or within 5mm of the origin of the LAD, LCX, or RCA
  • Involves a side branch >2.0 mm in diameter
  • Is at or distal to a 45º bend in the vessel
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Dr. J. Fajedet

    Clinique Pasteur

Other trials in France

About this study

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

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.

Being tested
Endeavor drug eluting coronary stent
Keywords
restenosis
Medical subject headings
Coronary Artery Disease, Arterial Occlusive Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia, Vascular Diseases, Ischemia, Arteriosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endeavor drug eluting coronary stentDevice

    Zotarolimus coated coronary stent (10ug/mm)

Study groups in NCT00614848
Study groupRoleWhat they receive
1ExperimentalEndeavor Drug Eluting Coronary Stent
Receives: Device: Endeavor drug eluting coronary stent
2Active comparatorDriver bare-metal coronary stent
Receives: Device: Endeavor drug eluting coronary stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target Vessel Failure Rate at 9 months post procedure

    Measured: 9 months

Secondary outcomes (1)

  1. 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

    Measured: 30 days and 6, 9, and 12 months, and annually thereafter out to 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2008 (estimated)
  2. Study startJun 2003
  3. Primary completionJan 2005
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00614848
Sponsor's protocol ID
IP034
Acronym
ENDEAVOR II
Status last verified
Apr 2011
First submitted
30 Jan 2008
Last updated
11 Apr 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Munzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE; ENDEAVOR II Investigators. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006 Aug 22;114(8):798-806. doi: 10.1161/CIRCULATIONAHA.105.591206. Epub 2006 Aug 14.

    PubMed 16908773

  • Mauri L, Massaro JM, Jiang S, Meredith I, Wijns W, Fajadet J, Kandzari DE, Leon MB, Cutlip DE, Thompson KP. Long-term clinical outcomes with zotarolimus-eluting versus bare-metal coronary stents. JACC Cardiovasc Interv. 2010 Dec;3(12):1240-9. doi: 10.1016/j.jcin.2010.08.021.

    PubMed 21232717

  • Remak E, Manson S, Hutton J, Brasseur P, Olivier E, Gershlick A. Cost-effectiveness of the Endeavor stent in de novo native coronary artery lesions updated with contemporary data. EuroIntervention. 2010 Feb;5(7):826-32. doi: 10.4244/eijv5i7a138.

    PubMed 20142198

  • Eisenstein EL, Wijns W, Fajadet J, Mauri L, Edwards R, Cowper PA, Kong DF, Anstrom KJ. Long-term clinical and economic analysis of the Endeavor drug-eluting stent versus the Driver bare-metal stent: 4-year results from the ENDEAVOR II trial (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). JACC Cardiovasc Interv. 2009 Dec;2(12):1178-87. doi: 10.1016/j.jcin.2009.10.011.

    PubMed 20129543

Questions about this trial

What is this clinical trial studying?

A study testing Endeavor drug eluting coronary stent in people with Coronary Artery Disease and Arterial Occlusive Diseases, run by Medtronic Vascular at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Vessel Failure Rate at 9 months post procedure (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00614848, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2011.

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