NCT00726453

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,516

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 25, 2012

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 23, 2016

Status Verified

April 1, 2016

Enrollment Period

2.5 years

First QC Date

July 30, 2008

Results QC Date

January 31, 2012

Last Update Submit

April 21, 2016

Conditions

Coronary Artery Disease

Keywords

TARGET VESSEL REVASCULARIZATION (TVR)MYOCARDIAL INFARCTION (MI)TARGET VESSEL FAILURE (TVF)TARGET LESION REVASCULARIZATION (TLR)TARGET LESION FAILURE (TLF)STENT THROMBOSISRESTENOTIC LESIONPERCUTANEOUS CORONARY INTERVENTION (PCI)

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 Months

Secondary Outcomes (5)

  • Target Vessel Failure (TVF)

    12 months

  • Major Adverse Cardiac Event (MACE)

    12 months

  • Death

    12 months

  • Target Vessel MI

    12 months

  • Stent Thrombosis (ST)

    12 months

Study Arms (1)

Resolute Zotarolimus-Eluting Coronary Stent

EXPERIMENTAL

Implantation of a Resolute Zotarolimus-Eluting Coronary Stent

Device: Resolute Zotarolimus-Eluting Coronary Stent

Interventions

Resolute Zotarolimus-Eluting Coronary StentDEVICE

Implantation of a Resolute Zotarolimus-Eluting Coronary Stent

Resolute Zotarolimus-Eluting Coronary Stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Texas Medical Center

Tyler, Texas, 75701, United States

Location

Related Publications (5)

  • 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.

    PMID: 24510638DERIVED

  • 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.

    PMID: 23523454DERIVED

  • 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.

    PMID: 23468513DERIVED

  • 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.

    PMID: 21570508DERIVED

  • 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.

    PMID: 21470813DERIVED

Related Links

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Results Point of Contact

Title
K. Bogdanovich
Organization
Medtronic Vascular
rs.medtroniccardiovascularclinicaltrials@medtronic.com

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2008

First Posted

August 1, 2008

Study Start

July 1, 2008

Primary Completion

January 1, 2011

Study Completion

March 1, 2016

Last Updated

May 23, 2016

Results First Posted

May 25, 2012

Record last verified: 2016-04

Locations

US(1)