Status:
COMPLETED
The Medtronic RESOLUTE US Clinical Trial
Lead Sponsor:
Medtronic Vascular
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of the study is to assess the safety and effectiveness of the Resolute Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a r...
Detailed Description
The trial is comprised of four studies: the 2.25 mm - 3.5 mm main study (1242 patients), the 2.25 mm - 3.5 mm Angio/IVUS sub-study (100 patients), the 4.0 mm sub-study (60 patients), and the 38 mm Len...
Eligibility Criteria
Inclusion
- 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) ≤ 27 mm in length (or ≤ 35 mm for a lesion to be treated with a 38 mm length stent)
- Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm, (or 3.0 to 4.2 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
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
1516 Patients enrolled
Trial Details
Trial ID
NCT00726453
Start Date
July 1 2008
End Date
March 1 2016
Last Update
May 23 2016
Active Locations (1)
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1
East Texas Medical Center
Tyler, Texas, United States, 75701