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

Medtronic Vascular65 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Arterial Occlusive Diseases Myocardial Ischemia Cardiovascular Diseases Coronary Artery Disease

Interventions

MDT-4107 Zotarolimus-Eluting Coronary StentDEVICE

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Shonan Kamakura General Hospital

Kanagawa, Japan

Outcomes

Primary Outcomes

Target Lesion Failure(TLF)

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)

Time frame: 9 month

Secondary Outcomes

MACE (Major Adverse Cardiac Event)

Death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary bypass, or clinically-driven repeat target lesion revascularization by percutaneous surgical methods.

Time frame: Baseline and 9 month

Late Lumen Loss

Defined as the difference between the post-procedure immediate minimal lumen diameter (MLD) and the follow-up angiography MLD at 9 month.

Time frame: Baseline and 9 months

Binary Angiographic Restenosis

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.

Time frame: Baseline and 9 month

Minimum Luminal Diameter

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.

Time frame: 9 month

Percent Diameter Stenosis

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).

Data from ClinicalTrials.gov

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