N/A
Completed N=65
RESOLUTE Japan SVS: The Clinical Evaluation of the MDT-4107 DES in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries
Arterial Occlusive Diseases · myocardial ischemia · Cardiovascular Disease · Coronary Artery Disease
Source: ClinicalTrials.gov NCT01150500 ↗
Enrolled (actual)
65
Serious AEs
24.6%
Results posted
Nov 2012
Primary outcomePrimary: Target Lesion Failure(TLF) — 4.62 percentage of TLF
Summary
The objective of the study is To verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows the use of 2.25mm diameter stents.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Target Lesion Failure(TLF) |
4.62 | — |
| SECONDARY MACE (Major Adverse Cardiac Event) |
2 | — |
| SECONDARY Late Lumen Loss |
0.27 | — |
| SECONDARY Binary Angiographic Restenosis |
1.5 | — |
| SECONDARY Minimum Luminal Diameter |
1.86 | — |
| SECONDARY Percent Diameter Stenosis |
12.92 | — |
| SECONDARY Clinical Endpoints |
— | — |
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 2.25 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 myocardial infarction (MI) within 72 hrs of the index procedure (Q wave myocardial infarction(QWMI)/non Q wave myocardial infarction (NQMI) or any elevation of creatinine kinease myocardial-band isoenzyme(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 (NCT01150500). 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.