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

UMIN ID: UMIN000000755

Registered date:02/07/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: ischemic heart disease
• Date of first enrollment: 2007/07/01
• Target sample size: 335
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Implantation of TRE-956
Implantation of Cypher

Outcome(s)

• Primary Outcome: TVF at 9M

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Evidence 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

• Primary Sponsor: Terumo corporation
• Source(s) of Monetary Support: Terumo corporation