OUtcome of Cypher stent with patients on Hemodialysis registry

Phase 4

• Conditions: Hemodialysis patients who undergo elective percutaneous coronary intervention (PCI) using sirolimus eluting stents

• Registration Number: JPRN-UMIN000001155
• Lead Sponsor: CITE group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-14
• Study Completion: 2010-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target vessel failure (TVF) including cardiac death, myocardial infarction in the target vessel and target vessel revascularization.

Secondary Outcome Measures

Name	Time	Method
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.