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

NCT01132456 | Completed DMC

• 1 other identifier: IP123
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Death

  30d, 6m, 9m, 12m, 18m, 2yr, 3yr

• MI

  30d, 6m, 9m, 12m, 18m, 2yr, 3yr

• Cardiac death and MI

  30d, 6m, 9m, 12m, 18m, 2yr, 3yr

• MACE

  30d, 6m, 9m, 12m, 18m, 2yr, 3yr

• 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

Study Arms (2)

Different patient subset

EXPERIMENTAL

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

38 mm Cohort

EXPERIMENTAL

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

Interventions

Drug eluting stent treatment DEVICE

Endeavor RESOLUTE Zotarolimus-Eluting Coronary Stent Implantation

38 mm Cohort; Different patient subset

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (1)

The Heart Care Clinic

Ahmedabad, Gujarat, 380015, India

Location

Related 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: 10.1016/j.amjcard.2013.06.012. Epub 2013 Aug 14.

  PMID: 23953695 RESULT

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Stenosis; Cardiovascular Diseases; Arteriosclerosis; Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases; Coronary Disease; Arterial Occlusive Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 28, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: April 1, 2016
• Last Updated: June 13, 2016

Record last verified: 2016-06

Locations

IN (1)