The Medtronic RESOLUTE Clinical Trial

October 18, 2011 updated by: Medtronic Vascular

The Clinical Response Evaluation of the Medtronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia
        • Monash Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late lumen loss (in-stent) as measured by quantitative coronary angiography (QCA)
Time Frame: 9 months
9 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Vascular

Investigators

  • Principal Investigator: Ian Meredith, Professor, Monash Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

November 1, 2005

First Submitted That Met QC Criteria

November 1, 2005

First Posted (Estimate)

November 3, 2005

Study Record Updates

Last Update Posted (Estimate)

October 20, 2011

Last Update Submitted That Met QC Criteria

October 18, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP069

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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