RESOLUTE Asia: A study in which data will be collected from patients with long lesion(s) and/or dual vessels who are suitable for stenting and who will be treated with Endeavor Resolute drug-eluting stent(s)
- Conditions
- Health Condition 1: null- Ischemic Heart DiseaseStenotic Coronary LesionCardiovascular DiseasesArteriosclerosisCoronary Artery Disease
- Registration Number
- CTRI/2009/091/000415
- Lead Sponsor
- Medtronic International Ltd Asia Pacific
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 411
General and Angiographic Inclusion Criteria highlights:
-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)
General and Angiographic Exclusion Criteria highlights:
-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
- Not specified
- Primary Outcome Measures
Name Time Method Target Lesion Failure (TLF) and Target Vessel Failure (TVF) <br/ ><br> <br/ ><br>TLF is defined as composite of cardiac death, target vessel <br/ ><br>myocardial infarction (Q wave and non-Q wave) or clinically-driven target <br/ ><br>lesion revascularization (TLR) by percutaneous or surgical methods. <br/ ><br>TVF defined as composite of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target vessel revascularization (TVR). <br/ ><br>Timepoint: 12 Months
- Secondary Outcome Measures
Name Time Method Cardiac death and MI:<br>Cardiac death and myocardial infarction (MI) rate in the studyTimepoint: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr;Death: <br/ ><br>Death rate in the studyTimepoint: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr;MACE:<br>MACE composite endpoint and each individual component (death,<br>myocardial infarction (MI) (Q wave and non-Q wave), emergent coronary<br>bypass surgery (CABG), or clinically-driven repeat target lesion<br>revascularization by percutaneous or surgical methods)<br>Timepoint: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr;MI:<br>Myocardial infarction (MI) rate in the studyTimepoint: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr;TLF: <br>Target Lesion Failure,<br>TLF composite endpoint and each individual component (cardiac death,<br>target vessel MI or clinically-driven TLR)<br>Timepoint: 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.