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

Not Applicable

Completed

• Conditions: Ischemic Heart Disease; Coronary Stenosis; Cardiovascular Diseases; Arteriosclerosis; Coronary Artery Disease

• Registration Number: NCT01132456
• Lead Sponsor: Medtronic Vascular

Brief Summary

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.

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 Timeline

• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Study Start: 2010-06
• Primary Completion: 2013-05
• Study Completion: 2016-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-09
• Last Update Posted: 2016-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF) for 38mm cohort and Target Vessel Failure (TVF) for dual vessel cohort	12 months	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

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

Trial Locations

Locations (1)

The Heart Care Clinic; 🇮🇳 Ahmedabad, Gujarat, India