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The Medtronic RESOLUTE US Clinical Trial (R-US)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resolute Zotarolimus-Eluting Coronary Stent
Sponsored by
Medtronic Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring TARGET VESSEL REVASCULARIZATION (TVR), MYOCARDIAL INFARCTION (MI), TARGET VESSEL FAILURE (TVF), TARGET LESION REVASCULARIZATION (TLR), TARGET LESION FAILURE (TLF), STENT THROMBOSIS, RESTENOTIC LESION, PERCUTANEOUS CORONARY INTERVENTION (PCI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • East Texas Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Resolute Zotarolimus-Eluting Coronary Stent

Arm Description

Implantation of a Resolute Zotarolimus-Eluting Coronary Stent

Outcomes

Primary Outcome Measures

Target Lesion Failure (TLF)
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)
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)
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
Target Vessel MI
Target Vessel MI (as determined by extended historical and ARC definitions).
Stent Thrombosis (ST)
Stent Thrombosis (ST) (as determined by historic and ARC definitions).

Full Information

First Posted
July 30, 2008
Last Updated
April 21, 2016
Sponsor
Medtronic Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT00726453
Brief Title
The Medtronic RESOLUTE US Clinical Trial
Acronym
R-US
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
TARGET VESSEL REVASCULARIZATION (TVR), MYOCARDIAL INFARCTION (MI), TARGET VESSEL FAILURE (TVF), TARGET LESION REVASCULARIZATION (TLR), TARGET LESION FAILURE (TLF), STENT THROMBOSIS, RESTENOTIC LESION, PERCUTANEOUS CORONARY INTERVENTION (PCI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1516 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resolute Zotarolimus-Eluting Coronary Stent
Arm Type
Experimental
Arm Description
Implantation of a Resolute Zotarolimus-Eluting Coronary Stent
Intervention Type
Device
Intervention Name(s)
Resolute Zotarolimus-Eluting Coronary Stent
Intervention Description
Implantation of a Resolute Zotarolimus-Eluting Coronary Stent
Primary Outcome Measure Information:
Title
Target Lesion Failure (TLF)
Description
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.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Target Vessel Failure (TVF)
Description
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).
Time Frame
12 months
Title
Major Adverse Cardiac Event (MACE)
Description
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).
Time Frame
12 months
Title
Death
Time Frame
12 months
Title
Target Vessel MI
Description
Target Vessel MI (as determined by extended historical and ARC definitions).
Time Frame
12 months
Title
Stent Thrombosis (ST)
Description
Stent Thrombosis (ST) (as determined by historic and ARC definitions).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin B Leon, MD
Organizational Affiliation
Columbia University College of Physicians & Surgeons
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Mauri, MD, MSc
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alex C Yeung, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Texas Medical Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24510638
Citation
Silber S, Kirtane AJ, Belardi JA, Liu M, Brar S, Rothman M, Windecker S. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J. 2014 Aug 1;35(29):1949-56. doi: 10.1093/eurheartj/ehu026. Epub 2014 Feb 7.
Results Reference
derived
PubMed Identifier
23523454
Citation
Silber S, Serruys PW, Leon MB, Meredith IT, Windecker S, Neumann FJ, Belardi J, Widimsky P, Massaro J, Novack V, Yeung AC, Saito S, Mauri L. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program. JACC Cardiovasc Interv. 2013 Apr;6(4):357-68. doi: 10.1016/j.jcin.2012.11.006. Epub 2013 Mar 20.
Results Reference
derived
PubMed Identifier
23468513
Citation
Farooq V, Vranckx P, Mauri L, Cutlip DE, Belardi J, Silber S, Widimsky P, Leon M, Windecker S, Meredith I, Negoita M, van Leeuwen F, Neumann FJ, Yeung AC, Garcia-Garcia HM, Serruys PW. Impact of overlapping newer generation drug-eluting stents on clinical and angiographic outcomes: pooled analysis of five trials from the international Global RESOLUTE Program. Heart. 2013 May;99(9):626-33. doi: 10.1136/heartjnl-2012-303368. Epub 2013 Mar 6.
Results Reference
derived
PubMed Identifier
21570508
Citation
Mauri L, Leon MB, Yeung AC, Negoita M, Keyes MJ, Massaro JM. Rationale and design of the clinical evaluation of the Resolute Zotarolimus-Eluting Coronary Stent System in the treatment of de novo lesions in native coronary arteries (the RESOLUTE US clinical trial). Am Heart J. 2011 May;161(5):807-14. doi: 10.1016/j.ahj.2011.03.015. Epub 2011 Mar 29.
Results Reference
derived
PubMed Identifier
21470813
Citation
Yeung AC, Leon MB, Jain A, Tolleson TR, Spriggs DJ, Mc Laurin BT, Popma JJ, Fitzgerald PJ, Cutlip DE, Massaro JM, Mauri L; RESOLUTE US Investigators. Clinical evaluation of the Resolute zotarolimus-eluting coronary stent system in the treatment of de novo lesions in native coronary arteries: the RESOLUTE US clinical trial. J Am Coll Cardiol. 2011 Apr 26;57(17):1778-83. doi: 10.1016/j.jacc.2011.03.005. Epub 2011 Apr 4.
Results Reference
derived
Links:
URL
http://www.medtronic.com
Description
Medtronic Home Page
URL
http://clinicaltrials.medtronic.com/
Description
Medtronic Clinical Trials Link

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The Medtronic RESOLUTE US Clinical Trial

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