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

NCT ID: NCT01132456

Last Updated: 2016-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2016-04-30

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.

Conditions

Ischemic Heart Disease; Coronary Stenosis; Cardiovascular Diseases; Arteriosclerosis; Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Drug eluting stent treatment

Intervention Type: DEVICE

Endeavor RESOLUTE Zotarolimus-Eluting Coronary Stent Implantation

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.

Group Type: EXPERIMENTAL

Drug eluting stent treatment

Intervention Type: DEVICE

Endeavor RESOLUTE Zotarolimus-Eluting Coronary Stent Implantation

Interventions

Drug eluting stent treatment

Endeavor RESOLUTE Zotarolimus-Eluting Coronary Stent Implantation

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Vascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robaayah Zambahari, MBBS, MRCP, FRCP, FACC

Role: PRINCIPAL_INVESTIGATOR

National Heart Institute (IJN), Malaysia

Michael Kang-Yin Lee, MBBS

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth Hospital, HK

Shirish Hiremath, MD

Role: PRINCIPAL_INVESTIGATOR

Ruby Hall Clinic, India

Locations

The Heart Care Clinic

Ahmedabad, Gujarat, India

Countries

India

References

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.

Reference Type: RESULT

PMID: 23953695 (View on PubMed)

Other Identifiers

IP123

Identifier Type: -

Identifier Source: org_study_id