NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001155

Registered date:14/05/2008

OUtcome of Cypher stent with patients on Hemodialysis registry

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedHemodialysis patients who undergo elective percutaneous coronary intervention (PCI) using sirolimus eluting stents
Date of first enrollment2007/07/01
Target sample size120
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Percutaneous coronary intervention (PCI) using sirolimus eluting stents

Outcome(s)

Primary OutcomeTarget vessel failure (TVF) including cardiac death, myocardial infarction in the target vessel and target vessel revascularization.
Secondary OutcomeBinary restenosis rate and late loss. Mortality and major adverse cardiac event rates at 12 months. Intimal hyperplasia measured by IVUS. Relation between dialysis membrane and MACE or lat loss. Relation between alpha 2 macroglobulin and late lumen loss.

Key inclusion & exclusion criteria

Age minimum21years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaPeritoneal dialysis. Cardiac arrest or survivor of sudden death. Cardiac shock. Emergent PCI. ST elevation myocardial infarction. Impossible to use antiplatelet drugs. Coronary stent implantation within 6 months. In stent restenosis lesion wihin drug eluting stents. Severe valvular disease. Critical limb ischemia. Chronic total occlusion as a target vessel.

Related Information

Contact

public contact
Name Yuji Ikari
Address 143 Shimokasuya, Isehara 259-1193 Japan
Telephone 0463-93-1121
E-mail ikari@is.icc.u-tokai.ac.jp
Affiliation Tokai University Cardiology
scientific contact
Name Yuji Ikari, MD, PhD
Address 143 Shimokasuya, Isehara, Kanagawa Japan
Telephone 0463-93-1121
E-mail ikari@is.icc.u-tokai.ac.jp
Affiliation Tokai University School of Medicine Cardiology