OUtcome of Cypher stent with patients on Hemodialysis registry

UMIN ID: UMIN000001155

Registered date:14/05/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hemodialysis patients who undergo elective percutaneous coronary intervention (PCI) using sirolimus eluting stents
• Date of first enrollment: 2007/07/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Percutaneous coronary intervention (PCI) using sirolimus eluting stents

Outcome(s)

• Primary Outcome: Target vessel failure (TVF) including cardiac death, myocardial infarction in the target vessel and target vessel revascularization.
• Secondary Outcome: Binary 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 minimum: 21years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Peritoneal 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

• Primary Sponsor: CITE group
• Source(s) of Monetary Support: Johnson & Johnson