Overview

This trial is active, not recruiting.

Conditions arterial occlusive diseases, myocardial ischemia, cardiovascular diseases, coronary artery disease
Treatment mdt-4107 zotarolimus-eluting coronary stent
Sponsor Medtronic Vascular
Start date June 2010
End date October 2011
Trial size 65 participants
Trial identifier NCT01150500, MDT2-07-05

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.
mdt-4107 zotarolimus-eluting coronary stent Endeavor Resolute, Zotarolimus Drug Eluting Stent, Medtronic
Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent

Primary Outcomes

Measure
Target Lesion Failure(TLF)
time frame: 9 month

Secondary Outcomes

Measure
MACE (Major Adverse Cardiac Event)
time frame: Baseline and 9 month
Late Lumen Loss
time frame: Baseline and 9 months
Binary Angiographic Restenosis
time frame: Baseline and 9 month
Minimum Luminal Diameter
time frame: 9 month
Percent Diameter Stenosis
time frame: Baseline and 9 month
Clinical Endpoints
time frame: 5 Years

Eligibility Criteria

Male or female participants at least 20 years old.

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 <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 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

Additional Information

Official title RESOLUTE JAPAN SVS: The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries
Principal investigator Shigeru Saito, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Medtronic Vascular.