Clinical trial NCT01132456: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2010-05-28
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Target Lesion Failure (TLF) for 38mm cohort and Target Vessel Failure (TVF) for dual vessel cohort
timeFrame: 12 months
Secondary outcomes:
measure: Death
timeFrame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr
measure: MI
timeFrame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr
measure: Cardiac death and MI
timeFrame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr
measure: MACE
timeFrame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr
measure: TLF
timeFrame: 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
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: The Heart Care Clinic
state: Gujarat
Study officials:
affiliation: National Heart Institute (IJN), Malaysia
name: Robaayah Zambahari, MBBS, MRCP, FRCP, FACC
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Elizabeth Hospital, HK
name: Michael Kang-Yin Lee, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruby Hall Clinic, India
name: Shirish Hiremath, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.