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)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Arteriosclerosis; Ischemic Heart Disease; Coronary Stenosis
• Intervention / Treatment: Device: Drug eluting stent treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 312
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380015
      • The Heart Care Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure (TLF) for 38mm cohort and Target Vessel Failure (TVF) for dual vessel cohort	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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death rate in the study.	30d, 6m, 9m, 12m, 18m, 2yr, 3yr
MI	Myocardial infarction (MI) rate in the study.	30d, 6m, 9m, 12m, 18m, 2yr, 3yr
Cardiac death and MI	Cardiac death and myocardial infarction (MI) rate in the study	30d, 6m, 9m, 12m, 18m, 2yr, 3yr
MACE	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)	30d, 6m, 9m, 12m, 18m, 2yr, 3yr
TLF	TLF composite endpoint and each individual component (cardiac death, target vessel MI or clinically-driven TLR)	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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: May 27, 2010
• First Posted (Estimate): May 28, 2010

Study Record Updates

• Last Update Posted (Estimate): June 13, 2016
• Last Update Submitted That Met QC Criteria: June 9, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: PERCUTANEOUS CORONARY INTERVENTION (PCI); MYOCARDIAL INFARCTION (MI); TARGET VESSEL REVASCULARIZATION (TVR); TARGET LESION REVASCULARIZATION (TLR); STENT THROMBOSIS; TARGET LESION FAILURE (TLF); TARGET VESSEL FAILURE (TVF); RESTENOTIC LESION; LONG LESION; DUAL VESSEL
• Additional Relevant MeSH Terms: Vascular Diseases; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Coronary Stenosis
• Other Study ID Numbers: IP123