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
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.
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.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Arterial Occlusive Diseases
Intervention
MDT-4107 Zotarolimus-Eluting Coronary Stent
Location
Shonan Kamakura General Hospital
Kanagawa
Japan
247-8533
Status
Active, not recruiting
Source
Medtronic Vascular
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01150500
- Information obtained from ClinicalTrials.gov on May 16, 2013
Medical and Biotech [MESH] Definitions
Angioplasty, Balloon
Use of a balloon catheter for dilatation of an occluded artery. It is used in treatment of arterial occlusive diseases, including renal artery stenosis and arterial occlusions in the leg. For the specific technique of balloon dilatation in coronary arteries, ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY is available.
Arterial Occlusive Diseases
Pathological processes which result in the partial or complete obstruction of ARTERIES. They are characterized by greatly reduced or absence of blood flow through these vessels. They are also known as arterial insufficiency.
Coronary Aneurysm
Abnormal balloon- or sac-like dilatation in the wall of CORONARY VESSELS. Most coronary aneurysms are due to CORONARY ATHEROSCLEROSIS, and the rest are due to inflammatory diseases, such as KAWASAKI DISEASE.
Arteriosclerosis Obliterans
Common occlusive arterial disease which is caused by ATHEROSCLEROSIS. It is characterized by lesions in the innermost layer (ARTERIAL INTIMA) of arteries including the AORTA and its branches to the extremities. Risk factors include smoking, HYPERLIPIDEMIA, and HYPERTENSION.
Coronary Vessel Anomalies
Malformations of CORONARY VESSELS, either arteries or veins. Included are anomalous origins of coronary arteries; ARTERIOVENOUS FISTULA; CORONARY ANEURYSM; MYOCARDIAL BRIDGING; and others.
Clinical Trials
RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent
The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent for the treatment of de novo lesions in native coronary arteries.
Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis
The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting stents for the reduction of Coronary Restenosis
Endeavor Zotarolimus - Eluting Stent in the Treatment Lesions in Small Native Coronary Arteries.
The Endeavor Zotarolimus-Eluting Coronary Stent System utilized in the ENDEAVOR SVS Registry is indicated for improving coronary luminal diameter in patients with ischemic heart disease du...
China Endeavor Registry: A Registry With The Endeavor Zotarolimus Eluting Coronary Stent in China
The safety and efficacy of the Endeavor(TM) Zotarolimus Eluting Coronary Stent System has been assessed in a series of studies. The stent is coated with a proprietary drug compound zotarol...
Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent
A Randomized Comparison of a Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) With a Zotarolimus-Eluting Stent (EndeavorTm, Medtronic) for Percutaneous Coronary Interventio...
PubMed Articles
The aim of this study was to investigate the impact of patient and lesion complexity on outcomes with newer-generation zotarolimus-eluting stents (ZES) and everolimus-eluting stents (EES).
The RESOLUTE US (R-US) trial is a prospective, observational study designed to evaluate the clinical effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in a U.S. population.
Aims: We investigated whether sirolimus-eluting stents (SES) are superior to next-generation zotarolimus-eluting stents (ZES) in treating patients with total coronary occlusions (TCO). Methods and res...
This study sought to compare the safety and efficacy of the Xience V/Promus everolimus-eluting stent (EES) (Abbott Vascular, Temecula, California) with the Endeavor Resolute zotarolimus-eluting stent...
A 73-year-old woman was admitted to our hospital with anterior acute myocardial infarction due to subacute thrombosis after coronary stenting with a zotarolimus-eluting stent (ZES), which is a newly d...
