The Medtronic RESOLUTE Clinical Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00248079
First received: November 1, 2005
Last updated: October 18, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: Coronary Artery Stenting
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Late lumen loss (in-stent) as measured by quantitative coronary angiography (QCA) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major adverse cardiac event (MACE) rate [ Time Frame: 30 days, 4, 6, 9 & 12 months ] [ Designated as safety issue: Yes ]
  • Acute success (device, lesion, and procedure) [ Time Frame: 4 or 9 Months ] [ Designated as safety issue: No ]
  • Target vessel failure (TVF) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization (TLR) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Neointimal hyperplastic volume and percent volume obstruction (%VO) as measured by intravascular ultrasound (IVUS) [ Time Frame: 4 or 9 months ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters [ Time Frame: last measurement at 60 days ] [ Designated as safety issue: No ]
  • Angiographic parameters (in-stent and in-segment) [ Time Frame: 4 or 9 months ] [ Designated as safety issue: No ]

Enrollment: 139
Study Start Date: November 2005
Study Completion Date: October 2011
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Coronary Artery Stenting
    Initial implant of drug eluting stent (zotarolimus)
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248079

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

No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00248079     History of Changes
Other Study ID Numbers: IP069
Study First Received: November 1, 2005
Last Updated: October 18, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Health Research Council

Keywords provided by Medtronic Vascular:
Coronary Disease

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

ClinicalTrials.gov processed this record on April 17, 2014