Status:
COMPLETED
RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent
Lead Sponsor:
Medtronic Vascular
Collaborating Sponsors:
Medtronic Japan Co., Ltd.
Conditions:
Arterial Occlusive Diseases
Myocardial Ischemia
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent for the treatment of de novo lesions in native coronary arteries.
Eligibility Criteria
Inclusion
- 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
- Target vessel(s) have reference vessel diameter 2.5 mm to 3.5 mm
Exclusion
- Within 7 days of implant platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; white blood cell (WBC) count \<3,000 cells/mm³; serum creatinine level \>2.5 mg/dl
- Acute myocadial infarction (MI) within 72 hrs of the index procedure (Q wave myocardial infarction(QWMI) or any elevation of Creatinine Kinase Mycocardial-band Isoemzyme (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 transient ischemic attack (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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00927940
Start Date
March 1 2009
End Date
February 1 2015
Last Update
May 5 2015
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Toyohashi Heart Center
Aichi, Japan, 441-8530
2
Hospital Hakodate Hokkaido
Hokkaido, Japan, 041-8680
3
Kansai Rosai Hospital
Hyōgo, Japan, 660-8511
4
Kanto Rosai Hospital
Kanagawa, Japan, 211-8510