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The Medtronic RESOLUTE US Clinical Trial (R-US)

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ClinicalTrials.gov Identifier: NCT00726453
Recruitment Status : Completed
First Posted : August 1, 2008
Results First Posted : May 25, 2012
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Tracking Information
First Submitted Date  ICMJE July 30, 2008
First Posted Date  ICMJE August 1, 2008
Results First Submitted Date  ICMJE January 31, 2012
Results First Posted Date  ICMJE May 25, 2012
Last Update Posted Date May 23, 2016
Study Start Date  ICMJE July 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
Target Lesion Failure (TLF) [ Time Frame: 12 Months ]
Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2008)
  • 2.5 mm - 3.5 mm group: Target lesion failure (TLF) [ Time Frame: 12 Months ]
  • 2.25 mm group: In-segment percent diameter stenosis (%DS) [ Time Frame: 8 months post-procedure ]
  • 4.0 mm group: In-segment late lumen loss (LLL) [ Time Frame: 8 months post-procedure ]
Change History Complete list of historical versions of study NCT00726453 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
  • Target Vessel Failure (TVF) [ Time Frame: 12 months ]
    Target Vessel Failure (TVF) composite endpoint and each individual component (Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods).
  • Major Adverse Cardiac Event (MACE) [ Time Frame: 12 months ]
    Major Adverse Cardiac Event (MACE) composite endpoint and each individual component (death, Target Vessel MI (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods).
  • Death [ Time Frame: 12 months ]
  • Target Vessel MI [ Time Frame: 12 months ]
    Target Vessel MI (as determined by extended historical and ARC definitions).
  • Stent Thrombosis (ST) [ Time Frame: 12 months ]
    Stent Thrombosis (ST) (as determined by historic and ARC definitions).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2008)
  • Various clinical endpoints per study group: Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis [ Time Frame: 12 months ]
  • Various angiographic endpoints per study group: Late lumen loss, binary angiographic restenosis, miniumum luminal diameter, percent diameter stenosis [ Time Frame: 8 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Medtronic RESOLUTE US Clinical Trial
Official Title  ICMJE A Clinical Evaluation of the Medtronic Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries With a Reference Vessel Diameter of 2.25 mm to 4.2mm
Brief Summary The objective of the study is to assess the safety and effectiveness of the Resolute Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm.
Detailed Description The trial is comprised of four studies: the 2.25 mm - 3.5 mm main study (1242 patients), the 2.25 mm - 3.5 mm Angio/IVUS sub-study (100 patients), the 4.0 mm sub-study (60 patients), and the 38 mm Length Sub-study (114 patients). A patient's inclusion in a given study is dependent on the size (diameter or length) of the stent(s) the patient receives.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Device: Resolute Zotarolimus-Eluting Coronary Stent
Implantation of a Resolute Zotarolimus-Eluting Coronary Stent
Study Arms  ICMJE Experimental: Resolute Zotarolimus-Eluting Coronary Stent
Implantation of a Resolute Zotarolimus-Eluting Coronary Stent
Intervention: Device: Resolute Zotarolimus-Eluting Coronary Stent
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2011)
1516
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2008)
1299
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

General and Angiographic Inclusion Criteria highlights:

  • Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
  • Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
  • Informed consent
  • Patient agrees to comply with specified follow-up evaluations at same investigational site
  • Single target lesion or two target lesions located in separate coronary arteries
  • De novo lesion(s) in native coronary artery(ies)
  • Target lesion(s) ≤ 27 mm in length (or ≤ 35 mm for a lesion to be treated with a 38 mm length stent)
  • Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm, (or 3.0 to 4.2 mm for it to be treated with a 38 mm length stent)

General and Angiographic Exclusion Criteria highlights:

  • Within 7 days of implant platelet count <100,000 cells/mm³ or >700,000 cells/mm³; WBC count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl
  • Acute MI within 72 hrs of the index procedure (QWMI or any elevation of CK-MB > lab upper limit of normal)
  • Previous PCI of target vessel(s) within 9 months prior to the procedure
  • Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
  • History of stroke or TIA within prior 6 months
  • Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
  • Inability to comply with required trial antiplatelet regimen
  • Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
  • Target vessel(s) has/have other lesions w/ > 40% diameter stenosis
  • Unprotected left main coronary artery disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00726453
Other Study ID Numbers  ICMJE IP102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Vascular
Study Sponsor  ICMJE Medtronic Vascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin B Leon, MD Columbia University College of Physicians & Surgeons
Principal Investigator: Laura Mauri, MD, MSc Brigham and Women's Hospital
Principal Investigator: Alex C Yeung, MD Stanford University
PRS Account Medtronic Vascular
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP