RESOLUTE Japan SVS: The Clinical Evaluation of the MDT-4107 DES in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries
NCT01150500 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2017-03-14
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.
Conditions
- Arterial Occlusive Diseases
- Myocardial Ischemia
- Cardiovascular Diseases
- Coronary Artery Disease
Interventions
- DEVICE
-
MDT-4107 Zotarolimus-Eluting Coronary Stent
Sponsors & Collaborators
-
Medtronic Vascular
lead INDUSTRY
Principal Investigators
-
Shigeru Saito, MD · Sohana Kamakura General Hosptial
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2011-10-31
- Completion
- 2016-06-30
Countries
- Japan
Study Locations
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