RESOLUTE Japan SVS: The Clinical Evaluation of the MDT-4107 DES in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries

Not Applicable

Completed

Conditions: Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Drug Eluting Stent	MDT-4107 Zotarolimus-Eluting Coronary Stent	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.

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure(TLF)	9 month	Target Lesion Failure (TLF) at 9 months post-procedure defined as a composite measure of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR)

Secondary Outcome Measures

Name	Time	Method
Clinical Endpoints	5 Years	Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis
Binary Angiographic Restenosis	Baseline and 9 month	Defined as =\> 50% in-stent diameter stenosis at the follow-up angiogram at 9 month. If an in-stent measurement is not available, the in-lesion diameter was used.
Percent Diameter Stenosis	Baseline and 9 month	The value calculated as 100 x (Reference Vessel Diameter(RVD) - Minimum luminal diameter(MLD))/ RVD using the mean values from orthogonal views (when possible) by quantitative coronary angiography(QCA).
Late Lumen Loss	Baseline and 9 months	Defined as the difference between the post-procedure immediate minimal lumen diameter (MLD) and the follow-up angiography MLD at 9 month.
MACE (Major Adverse Cardiac Event)	Baseline and 9 month	Death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary bypass, or clinically-driven repeat target lesion revascularization by percutaneous surgical methods.
Minimum Luminal Diameter	9 month	The average of two orthogonal views(when possible) of narrowest point within the area of assessment-in lesion, in stent or in segment. minimal luminal diameter is visually estimated during angiography by the investigator; it is measured during quantitative coronary angiography by the Angiographic Core Laboratory.