The Medtronic RESOLUTE US Clinical Trial (R-US)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medtronic Vascular Identifier:
First received: July 30, 2008
Last updated: October 30, 2013
Last verified: October 2013

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.

Condition Intervention
Coronary Artery Disease
Device: Resolute Zotarolimus-Eluting Coronary Stent

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Target Lesion Failure (TLF) [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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.

Secondary Outcome Measures:
  • Target Vessel Failure (TVF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Target Vessel MI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Target Vessel MI (as determined by extended historical and ARC definitions).

  • Stent Thrombosis (ST) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Stent Thrombosis (ST) (as determined by historic and ARC definitions).

Enrollment: 1516
Study Start Date: July 2008
Estimated Study Completion Date: June 2016
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resolute Zotarolimus-Eluting Coronary Stent
Implantation of a Resolute Zotarolimus-Eluting Coronary Stent
Device: Resolute Zotarolimus-Eluting Coronary Stent
Implantation of a Resolute Zotarolimus-Eluting Coronary Stent
Other Name: Resolute Zotarolimus-Eluting Coronary Stent

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.


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

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00726453

United States, Texas
East Texas Medical Center
Tyler, Texas, United States, 75701
Sponsors and Collaborators
Medtronic Vascular
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
  More Information

Additional Information:
No publications provided by Medtronic Vascular

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

Responsible Party: Medtronic Vascular Identifier: NCT00726453     History of Changes
Other Study ID Numbers: IP102
Study First Received: July 30, 2008
Results First Received: January 31, 2012
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Vascular:

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents processed this record on April 17, 2014