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

Coronary Artery Disease Clinical Trial

— R-A  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132456
• Other study ID #: IP123
• Status: Completed
• Phase: N/A
• First received: May 26, 2010
• Last updated: June 9, 2016
• Start date: June 2010
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Directorate of Drug AdministrationMalaysia: Ministry of HealthHong Kong: Department of HealthIndia: Ministry of HealthIndonesia: Departement Kesehatan (Department of Health)Korea: Food and Drug AdministrationSingapore: Health Sciences AuthorityTaiwan: Department of HealthThailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: April 2016
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Drug eluting stent treatment
Endeavor RESOLUTE Zotarolimus-Eluting Coronary Stent Implantation

Locations

Country	Name	City	State
India	The Heart Care Clinic	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

India, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Death	Death rate in the study.	30d, 6m, 9m, 12m, 18m, 2yr, 3yr	Yes
Secondary	MI	Myocardial infarction (MI) rate in the study.	30d, 6m, 9m, 12m, 18m, 2yr, 3yr	Yes
Secondary	Cardiac death and MI	Cardiac death and myocardial infarction (MI) rate in the study	30d, 6m, 9m, 12m, 18m, 2yr, 3yr	Yes
Secondary	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	Yes
Secondary	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	No