NIPH Clinical Trials Search

UMIN ID: UMIN000000755

Registered date:02/07/2007

Multi-center prospective randomized control trial of Biolimus Eluting Stent System(TRE-956)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedischemic heart disease
Date of first enrollment2007/07/01
Target sample size335
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Implantation of TRE-956 Implantation of Cypher


Primary OutcomeTVF at 9M
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaEvidence of an acute myocardial infarction within 72 hours of the intended treatment. Stroke or transient ischemic attack within the prior 90 days. Active peptic ulcer or upper GI bleeding within the prior 180days. Documented LVEF <30%. Patient has received a immunosuppressant. Planned surgery with antiplatelet drug withdrawal after index procedure. Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment. Previous DES ( less than 1 year) anywhere within the target vessel . Significant (>50%) stenosis proximal or distal to the target lesion . Ostial or bifurcation target lesion Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated. Target lesion is located or supplied by an arterial or venous bypass graft. Target lesion involves a side branch >2.0mm in diameter. The target lesion requires treatment with a device other than PTCA prior to stent placement . Unprotected Left main coronary artery disease (stenosis >50%).

Related Information


public contact
Address Japan
Affiliation Terumo corporation Clinical development department
scientific contact
Name Kazuaki Mitsudo,MD , Hidehiko Honda.MD
Address 1-1-1 Miwa,Kurashiki City,Okayama Prefecture ,Japan ,4-15 Hirose-cho,Aoba district,Sendai City,Miyagi Prefecture,Japan Japan
Affiliation Kurashiki central hospital Sendai kousei hospital Cardiology ,Cardiology