N/A
Completed N=100
RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent
Arterial Occlusive Diseases · myocardial ischemia · Cardiovascular Disease · Coronary Artery Disease
Source: ClinicalTrials.gov NCT00927940 ↗
Enrolled (actual)
100
Serious AEs
35.0%
Results posted
Jul 2012
Primary outcomePrimary: In-stent Late Lumen Loss (LLL) — 0.13 mm
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In-stent Late Lumen Loss (LLL) |
0.13 | — |
| SECONDARY Percent of Patient With Target Lesion Failure(Major Secondary Endpoint) |
4.0 | — |
| SECONDARY Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis |
— | — |
| SECONDARY Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO) |
— | — |
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) ≤ 27 mm in length
- Target vessel(s) have reference vessel diameter 2.5 mm to 3.5 mm
Exclusion Criteria
- Within 7 days of implant platelet count 700,000 cells/mm³; white blood cell (WBC) count 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
Data sourced from ClinicalTrials.gov (NCT00927940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.