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: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Ischemic Heart Disease
Stenotic Coronary Lesion
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease
Device: Drug eluting stent treatment

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

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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)


Enrollment: 312
Study Start Date: June 2010
Estimated Study Completion Date: April 2016
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Drug eluting stent treatment
Endeavor RESOLUTE Zotarolimus-Eluting Coronary Stent Implantation
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.
Device: Drug eluting stent treatment
Endeavor RESOLUTE Zotarolimus-Eluting Coronary Stent Implantation

Detailed Description:

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.
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132456

Locations
India
The Heart Care Clinic
Ahmedabad, Gujarat, India, 380015
Sponsors and Collaborators
Medtronic Vascular
Investigators
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
  More Information

Publications:
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01132456     History of Changes
Other Study ID Numbers: IP123
Study First Received: May 26, 2010
Last Updated: May 30, 2014
Health Authority: Bangladesh: Directorate of Drug Administration
Malaysia: Ministry of Health
Hong Kong: Department of Health
India: Ministry of Health
Indonesia: Departement Kesehatan (Department of Health)
Korea: Food and Drug Administration
Singapore: Health Sciences Authority
Taiwan: Department of Health
Thailand: Food and Drug Administration

Keywords provided by Medtronic Vascular:
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)
LONG LESION
DUAL VESSEL

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014