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

Study Overview
=================
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.

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

Conditions
-----------------
Arterial Occlusive Diseases, Myocardial Ischemia, Cardiovascular Diseases, Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: MDT-4107 Zotarolimus-Eluting Coronary Stent


Participation Criteria
=================
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 <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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug Eluting Stent<br>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. | Device: MDT-4107 Zotarolimus-Eluting Coronary Stent<br> <br> * Other names: Endeavor Resolute, Zotarolimus Drug Eluting Stent, Medtronic;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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). | Baseline and 9 month | 
| Clinical Endpoints | Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis | 5 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medtronic, Japan, Arterial Occlusive Diseases, Myocardial Ischemia, Cardiovascular Diseases, Coronary Artery Disease, Small Vessel Stent