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Coronary Artery DiseaseENDEAVOR IIINCT00217256

The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial

A study testing Percutaneous Coronary Stenting in people with Coronary Artery Disease, run by Medtronic Vascular.

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 equivalency in in-segment late lumen loss at 8 months between the Endeavor Drug Eluting Coronary Stent System coated with ABT-578 (10 micrograms/mm) and the Cypher Sirolimus-Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries 2.5-3.5 mm in diameter. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Percutaneous Coronary Stenting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
436 participants
Where
No sites listed yet
Study dates
Feb 2004to Dec 2010
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

  • The patient is at least 18 years of age.
  • The patient must have clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study.
  • The patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergent coronary artery bypass graft (CABG) surgery.
  • Female patients of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure.
  • The patient 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 of the respective clinical site.
  • The patient and the treating physician agree that the patient will return to the treating research center, or an affiliated institution under the same IRB jurisdiction, for all required post-procedure follow-up visits. A research staff member who has been properly trained to the Endeavor III protocol must conduct all follow-up evaluations.

Who cannot join

  • A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, cobalt, nickel, chromium, molybdenum, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
  • History of an allergic reaction or significant sensitivity to drugs similar to ABT-578 (rapamycin or rapamycin analog).
  • A platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a WBC < 3,000 cells/mm³.
  • A creatinine level > 2.0 mg/dL.
  • Evidence of an acute myocardial infarction within 72 hours of the intended treatment (defined as: Q wave or non-Q wave myocardial infarction having creatine kinase (CK) enzymes greater than or equal to 2X the upper laboratory normal with the presence of a creatine kinase myocardial-band isoenzyme (CK-MB) elevated above the Institution's upper limit of normal).
  • Any previous or planned treatment of any vessel with a drug eluting stent.
Show all 15Show fewer
  • Previous or planned percutaneous coronary intervention of any vessel within 30 days pre or post procedure.
  • Previous stenting anywhere in the target vessel.
  • During the index procedure, the target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, cutting balloon, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.).
  • History of a stroke or transient ischemic attack within the prior 6 months.
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
  • 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 of the target vessel with anti-restenotic therapies including, but not limited to 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; or requires coronary angiography, intravascular ultrasound (IVUS) or other coronary artery imaging procedures.

About this study

Official title: A Randomized Controlled Trial of the Medtronic Endeavor Drug (ABT-578) Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions

To demonstrate the equivalency in in-segment late lumen loss at 8 months between the Endeavor Drug Eluting Coronary Stent System coated with ABT-578 (10 micrograms/mm) and the Cypher Sirolimus-Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries 2.5-3.5 mm in diameter.

Read the detailed description

The ENDEAVOR III Trial is a prospective, multi-center, single-blind, randomized trial that enrolled 436 patients at 29 sites in the US. The purpose of this trial is to demonstrate the equivalency of in-segment late lumen loss at 8 months between the Endeavor stent and the Cypher stent for the treatment of single de novo lesions in native coronary arteries 2.5-3.5 mm in diameter. Patients were randomized to receive the Endeavor stent or the Cypher Sirolimus-Eluting Coronary Stent System. Enrollment was completed in September 2004.

Being tested
Percutaneous Coronary Stenting
Keywords
Restenosis
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Percutaneous Coronary StentingDevice

    Endeavor Drug Eluting Stent

  • Percutaneous Coronary StentingDevice

    Cypher Drug Eluting Stent

Study groups in NCT00217256
Study groupRoleWhat they receive
1ExperimentalEndeavor Drug Eluting Stent
Receives: Device: Percutaneous Coronary Stenting
2Active comparatorCypher Drug Eluting Stent
Receives: Device: Percutaneous Coronary Stenting

What is being measured

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

  1. In-segment late lumen loss

    Measured: 8 months

Secondary outcomes (10)

  1. Device Success

    Measured: 9 months

  2. Lesion Success

    Measured: 9 months

  3. Procedure Success

    Measured: 9 months

  4. Major Adverse Cardiac Event (MACE) rate

    Measured: 30 days, 6, 9, and 12 months

  5. Target Site Revascularization (TSR) rate and clinically-driven TSR rate

    Measured: 9 months

  6. Target Vessel Revascularization (TVR) rate and clinically-driven TVR rate

    Measured: 9 months

  7. Target Vessel Failure (TVF) rate

    Measured: 9 months

  8. Angiographic binary restenosis (> 50% diameter stenosis) rate

    Measured: 8 months

  9. In-stent and in-segment minimum lumen diameter (MLD)

    Measured: 8 months

  10. Neointimal hyperplastic volume as measured by IVUS

    Measured: 8 months

Timeline

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

  1. First posted22 Sep 2005 (estimated)
  2. Study startFeb 2004
  3. Primary completionMay 2005
  4. Study completionDec 2010

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
436 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00217256
Sponsor's protocol ID
IP056
Acronym
ENDEAVOR III
Status last verified
Jun 2011
First submitted
14 Sep 2005
Last updated
27 Jun 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Kandzari DE, Mauri L, Popma JJ, Turco MA, Gurbel PA, Fitzgerald PJ, Leon MB. Late-term clinical outcomes with zotarolimus- and sirolimus-eluting stents. 5-year follow-up of the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2011 May;4(5):543-50. doi: 10.1016/j.jcin.2010.12.014.

    PubMed 21596327

  • 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, Leon MB, Kandzari DE, Mauri L, Edwards R, Kong DF, Cowper PA, Anstrom KJ; ENDEAVOR III Investigators. Long-term clinical and economic analysis of the Endeavor zotarolimus-eluting stent versus the cypher sirolimus-eluting stent: 3-year results from the ENDEAVOR III trial (Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2009 Dec;2(12):1199-207. doi: 10.1016/j.jcin.2009.10.009.

    PubMed 20129546

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Coronary Stenting in people with Coronary Artery Disease, run by Medtronic Vascular.

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 6 inclusion and 15 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 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

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?

In-segment late lumen loss (time frame: 8 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 NCT00217256, which also lists 3 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 27 Jun 2011.

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