RESOLUTE Japan SVS: The Clinical Evaluation of the MDT-4107 DES in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries (RJ-SVS)
|ClinicalTrials.gov Identifier: NCT01150500|
Recruitment Status : Completed
First Posted : June 25, 2010
Results First Posted : November 30, 2012
Last Update Posted : March 14, 2017
|Condition or disease||Intervention/treatment|
|Arterial Occlusive Diseases Myocardial Ischemia Cardiovascular Diseases Coronary Artery Disease||Device: MDT-4107 Zotarolimus-Eluting Coronary Stent|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2010|
|Primary Completion Date :||October 2011|
|Study Completion Date :||June 2016|
Experimental: Drug Eluting 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.
Device: MDT-4107 Zotarolimus-Eluting Coronary Stent
Other Name: Endeavor Resolute, Zotarolimus Drug Eluting Stent, Medtronic
- Target Lesion Failure(TLF) [ Time Frame: 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)
- MACE (Major Adverse Cardiac Event) [ Time Frame: 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.
- Late Lumen Loss [ Time Frame: 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.
- Binary Angiographic Restenosis [ Time Frame: 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.
- Minimum Luminal Diameter [ Time Frame: 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.
- Percent Diameter Stenosis [ Time Frame: 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).
- Clinical Endpoints [ Time Frame: 5 Years ]Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150500
|Shonan Kamakura General Hospital|
|Kanagawa, Japan, 247-8533|
|Principal Investigator:||Shigeru Saito, MD||Sohana Kamakura General Hosptial|