Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

RESOLUTE Asia: Evaluation of the Endeavor Resolute Zotarolimus-Eluting Stent System in a Patient Population With Long Lesion(s) and/or Dual Vessels in Asia (R-A)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01132456
First received: May 26, 2010
Last updated: October 31, 2014
Last verified: October 2014

May 26, 2010
October 31, 2014
June 2010
May 2013   (final data collection date for primary outcome measure)
Target Lesion Failure (TLF) for 38mm cohort and Target Vessel Failure (TVF) for dual vessel cohort [ Time Frame: 12 months ] [ Designated as safety issue: No ]
TLF is defined as composite of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods. TVF is defined as composite of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target vessel revascularization (TVR).
Same as current
Complete list of historical versions of study NCT01132456 on ClinicalTrials.gov Archive Site
  • Death [ Time Frame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr ] [ Designated as safety issue: Yes ]
    Death rate in the study.
  • MI [ Time Frame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr ] [ Designated as safety issue: Yes ]
    Myocardial infarction (MI) rate in the study.
  • Cardiac death and MI [ Time Frame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr ] [ Designated as safety issue: Yes ]
    Cardiac death and myocardial infarction (MI) rate in the study
  • MACE [ Time Frame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr ] [ Designated as safety issue: Yes ]
    MACE composite endpoint and each individual component (death, myocardial infarction (MI) (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods)
  • TLF [ Time Frame: For 38mm cohort it is 30d, 6m, 9m, 18m, 2yr and 3yr. For dual vessel cohort it is 30d, 6m, 9m, 12m, 18m, 2yr and 3yr ] [ Designated as safety issue: No ]
    TLF composite endpoint and each individual component (cardiac death, target vessel MI or clinically-driven TLR)
Same as current
Not Provided
Not Provided
 
RESOLUTE Asia: Evaluation of the Endeavor Resolute Zotarolimus-Eluting Stent System in a Patient Population With Long Lesion(s) and/or Dual Vessels in Asia
RESOLUTE Asia: Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Patient Population With Long Lesion(s) and/or Dual Vessels in Asia

The purpose of this study is to document the safety and overall clinical performance of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a patient population with long lesion(s) and/or dual vessels requiring stent implantation.

A total of 249 to 411 patients will be enrolled from Asia at approximately 25 centers where Endeavor Resolute stent is commercially available. There are two study cohorts:

  1. 38 mm cohort: a minimum of 46 patients and maximum of 111 patients with at least one lesion amenable to treatment with a 38 mm length Endeavor Resolute stent. Patients may have one or two lesions, if the two lesions are located in separate target vessels.
  2. Dual vessel cohort: a minimum of 203 patients and maximum of 300 patients with dual vessel treatment where each vessel has a lesion with length ≤ 27 mm and reference vessel diameters between 2.25 mm and 4.0 mm.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ischemic Heart Disease
  • Stenotic Coronary Lesion
  • Cardiovascular Diseases
  • Arteriosclerosis
  • Coronary Artery Disease
Device: Drug eluting stent treatment
Endeavor RESOLUTE Zotarolimus-Eluting Coronary Stent Implantation
  • Experimental: Different patient subset
    Patients with dual vessel treatment where each vessel has a lesion with length ≤ 27 mm and reference vessel diameters between 2.25 mm and 4.0 mm.
    Intervention: Device: Drug eluting stent treatment
  • Experimental: 38 mm Cohort
    Patients with at least one lesion amenable to treatment with a 38 mm length Endeavor Resolute stent. Patients may have one or two lesions, if the two lesions are located in separate target vessels.
    Intervention: Device: Drug eluting stent treatment
Lee M, Hiremath S, Zambahari R, Leon M, Mauri L, Yeung A; RESOLUTE US and RESOLUTE Asia Investigators. One-year outcomes of percutaneous coronary intervention with the 38-mm Resolute zotarolimus-eluting stent. Am J Cardiol. 2013 Nov 1;112(9):1335-41. doi: 10.1016/j.amjcard.2013.06.012. Epub 2013 Aug 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
312
April 2016
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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) ≤ 35 mm in length (or both lesion lengths ≤ 27 mm for two lesions in separate target vessels to be considered for the dual vessel cohort)
  • Target vessel(s) have reference vessel diameter 2.25 mm to 4.0 mm, (or 3.0 to 4.0 mm for it to be treated with a 38 mm length stent)

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01132456
IP123
Yes
Medtronic Vascular
Medtronic Vascular
Not Provided
Principal Investigator: Robaayah Zambahari, MBBS, MRCP, FRCP, FACC National Heart Institute (IJN), Malaysia
Principal Investigator: Michael Kang-Yin Lee, MBBS Queen Elizabeth Hospital, HK
Principal Investigator: Shirish Hiremath, MD Ruby Hall Clinic, India
Medtronic Vascular
October 2014

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