Endeavor Zotarolimus - Eluting Stent in the Treatment Lesions in Small Native Coronary Arteries. (ENDEAVORSVS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00609947
Recruitment Status : Completed
First Posted : February 7, 2008
Results First Posted : January 26, 2015
Last Update Posted : February 9, 2015
Information provided by (Responsible Party):
Medtronic Vascular

Brief Summary:
The objective of this study is to verify the safety and efficacy of the Endeavor Zotarolimus-Eluting Coronary Stent System for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length ≤27 mm in native coronary arteries with reference vessels ≥ 2.25 mm to ≤ 2.75 mm.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Endeavor Zotarolimus-Eluting Coronary Stent Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries
Study Start Date : January 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: Endeavor Zotarolimus-Eluting Coronary Stent
Zotarolimus-eluting stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach
Device: Endeavor Zotarolimus-Eluting Coronary Stent
Other Name: Endeavor

Primary Outcome Measures :
  1. In-segment Percent Diameter Stenosis at 8 Months Post-procedure [ Time Frame: 8 months post-procedure ]
    In-segment percent diameter stenosis at 8 months post-procedure with percent diameter stenosis defined as the value calculated as 100 x (RVD - Minimal Lumen Diameter (MLD)/RVD using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiography (QCA).

  2. Major Adverse Cardiac Events (MACE) Rate [ Time Frame: 12 months post-procedure ]
    Major Adverse Cardiac Events rate at 12 months post-procedure defined as death, target-vessel Myocardial Infarction (Q wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization, repeat percutaneous transluminal coronary angioplasty or cardiac bypass surgery.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • The patient is ≥18 years of age.
  • The patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or positive functional study.
  • The patient is an acceptable candidate for Percutaneous Transluminal Coronary Angiography (PTCA), stenting, and emergent Coronary Artery Bypass Grafting (CABG) surgery.
  • Female patients of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
  • The patient or patient'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 of the respective clinical site.
  • The patient agrees to return to same research facility for all required post-procedure follow-up visits.


1. The target lesion/vessel must meet the following criteria:

  1. The patient requires treatment of either:

    • A single de novo lesion located in a native coronary artery amenable to treatment with a 2.25mm, 2.5mm or 2.75mm stent, or
    • Two de novo lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.25mm, 2.5mm, or 2.75mm stent and the second lesion amenable to treatment with a 2.25mm, 2.5mm, or 2.75mm stent or a 3.0mm or 3.5mm approved Endeavor stent.
  2. The lesion(s) must be ≤ 27mm in length.
  3. The lesion(s) must have a stenosis of ≥ 50% and < 100%.
  4. The vessel(s) has (have) a thrombolysis in myocardial infarction (TIMI) flow 2 or greater.
  5. The target vessel reference diameter must be ≥ 2.25mm and ≤ 2.75mm and the second target vessel reference diameter, if present, must be ≥ 2.25mm and ≤ 3.5mm.
  6. All target lesions can be treated with a Medtronic Endeavor stent.


  1. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticlopidine, clopidogrel, cobalt, nickel, chromium, molybdenum, polymer coatings, or sensitivity to contrast media, which cannot be adequately pre-medicated
  2. History of allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
  3. Platelet count <100,000 cells/mm³ or >700,000 cells/mm³, or white blood cell count <3,000 cells/mm³
  4. Serum creatinine level >2.0 mg/dl within 7 days prior to index procedure
  5. Evidence of acute MI within 72 hours of intended index procedure
  6. Planned PCI of any vessel within 30 days pre or post-index procedure and/or planned PCI of the target vessel(s) within 12 months post-procedure.
  7. During the index procedure, the target lesion(s) requires treatment with a device other than PTCA prior to stent placement
  8. History of stroke or transient ischemic attack (TIA) within prior 6 months
  9. Active peptic ulcer or upper gastrointestinal (GI) bleeding within prior 6 months.
  10. History of bleeding diathesis or coagulopathy or patient will refuse blood transfusions.
  11. Concurrent medical condition with life expectancy of less than 12 months.
  12. Any previous or planned treatment of target vessel with anti-restenotic therapies including but not limited to brachytherapy.
  13. Currently participating in an investigational drug or another device study that has not completed primary endpoint or that clinically interferes with current study endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures.
  14. Documented left ventricular ejection fraction (LVEF) <30% at most recent evaluation.
  15. Inability to comply with protocol required medication regimen ANGIOGRAPHIC EXCLUSION CRITERIA

1. Target lesion(s) located in native vessel distal to anastomosis with saphenous vein graft or a left/right internal mammary artery bypass with >40% diameter stenosis anywhere within graft.

2. Previous stenting in the target vessel(s) unless the following conditions are met:

a. It has been at least 9 months since the previous stenting, and b. The target lesion(s) is/are at least 15mm away from the previously placed stent.

3. Target vessel has other lesions with >40% diameter stenosis based on visual estimate or on-line QCA 4. Target vessel(s) has/have evidence of thrombus 5. Target vessel(s) is excessively tortuous (two bends ≥90º to reach target lesion) 6. Target lesion has any of the following characteristics:

  1. Location is aorto-ostial, an unprotected left main lesion, or within 5 mm of the origin of the left anterior descending (LAD), left circumflex (LCX), or right coronary artery (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
  5. Involves a bifurcation 7. Unprotected left main coronary artery disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00609947

United States, South Carolina
AnMed Health Medical Center
Anderson, South Carolina, United States, 29621
Sponsors and Collaborators
Medtronic Vascular
Principal Investigator: Martin B Leon, MD Columbia University

Responsible Party: Medtronic Vascular Identifier: NCT00609947     History of Changes
Other Study ID Numbers: IP057
First Posted: February 7, 2008    Key Record Dates
Results First Posted: January 26, 2015
Last Update Posted: February 9, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs