The Medtronic RESOLUTE Clinical Trial

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: NCT00248079
Recruitment Status : Completed
First Posted : November 3, 2005
Last Update Posted : October 20, 2011
Information provided by (Responsible Party):
Medtronic Vascular

Brief Summary:
To evaluate the clinical safety, efficacy, and pharmacokinetics (PK) of the Endeavor Resolute Zotorolimus Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter (RVD) between 2.5 and 3.5 mm in diameter.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Coronary Artery Stenting Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Response Evaluation of the Medtronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
Study Start Date : November 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Coronary Artery Stenting
    Initial implant of drug eluting stent (zotarolimus)

Primary Outcome Measures :
  1. Late lumen loss (in-stent) as measured by quantitative coronary angiography (QCA) [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Major adverse cardiac event (MACE) rate [ Time Frame: 30 days, 4, 6, 9 & 12 months ]
  2. Acute success (device, lesion, and procedure) [ Time Frame: 4 or 9 Months ]
  3. Target vessel failure (TVF) [ Time Frame: 9 months ]
  4. Target lesion revascularization (TLR) [ Time Frame: 9 months ]
  5. Neointimal hyperplastic volume and percent volume obstruction (%VO) as measured by intravascular ultrasound (IVUS) [ Time Frame: 4 or 9 months ]
  6. Pharmacokinetic parameters [ Time Frame: last measurement at 60 days ]
  7. Angiographic parameters (in-stent and in-segment) [ Time Frame: 4 or 9 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patient is at least 18 years old
  2. Patient is an acceptable candidate for percutaneous coronary intervention and emergent coronary artery bypass graft surgery
  3. Patient has clinical evidence of ischemic heart disease or a positive functional study
  4. Female patients of childbearing potential must have a negative pregnancy test within 7 days before the trial procedure
  5. Patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by Human Research Ethics Committee of the respective investigational site
  6. Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed. Patients participating in the PK sub-study must agree to the additional follow-up procedures as required by the sub-study

Exclusion Criteria:

  1. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coating components or a sensitivity to contrast media, which cannot be adequately pre-medicated
  2. History of an allergic reaction or significant sensitivity to drugs such as ABT-578, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
  3. Platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³
  4. Serum creatinine level > 170 micromol/L within 7 days prior to index procedure
  5. Evidence of an acute myocardial infarction within 72 hours of the intended trial procedure (defined as: Q wave myocardial infarction or non-Q wave myocardial infarction having CK enzymes > 2X the laboratory upper limit of normal with the presence of an elevated CK-MB (any amount above the laboratory upper limit of normal))
  6. Previous stenting anywhere in the target vessel
  7. PCI of the target vessel within 30 days prior to the procedure
  8. Implantation of a drug eluting stent in any non-target vessel within 30 days prior to the procedure. Implantation of a Cypher stent in any non-target vessel within 90 days prior to the procedure
  9. PCI of a non-target vessel with a bare metal stent within 30 days prior to the procedure that results in any MACE event. If the bare metal stent is implanted within 72 hours prior to the procedure, a post procedural serial CK or CK-MB measurement above the investigational site's upper limit of normal (two below upper normal required for enrollment)
  10. PCI of a non-target vessel within 24 hours prior to the procedure
  11. Planned PCI of any vessel within 30 days post-procedure. Planned stenting of any vessel with a Cypher or Endeavor stent within 60 days post-procedure
  12. Planned PCI of the target vessel within 9 months post-procedure
  13. During the index procedure, the target lesion requires treatment with a device other than PTCA prior to stent placement
  14. History of a stroke or transient ischemic attack within the prior 6 months
  15. Active peptic ulcer or upper gastrointestinal bleeding within the prior 6 months
  16. History of bleeding diathesis or coagulopathy or will refuse blood transfusions
  17. Concurrent medical condition with a life expectancy of less than 12 months
  18. Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy
  19. Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures
  20. Documented left ventricular ejection fraction < 30% at the most recent evaluation

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): NCT00248079

Monash Medical Centre
Melbourne, Australia
Sponsors and Collaborators
Medtronic Vascular
Principal Investigator: Ian Meredith, Professor Monash Medical Centre

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Medtronic Vascular Identifier: NCT00248079     History of Changes
Other Study ID Numbers: IP069
First Posted: November 3, 2005    Key Record Dates
Last Update Posted: October 20, 2011
Last Verified: October 2011

Keywords provided by Medtronic Vascular:
Coronary Disease

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