NCT00323895

The Intra-Drug Eluting Stent (DES) Restenosis Study

A Prospective, Randomized, Multi-Center Comparison of the CYPHER Select™ Sirolimus-Eluting Stent and Balloon Re-Angioplasty for Treatment of Patients With Intra-Des Restenosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Prospective, Randomized, Multi-Center Comparison of the Cypher Select™ Sirolimus-Eluting Stent and Balloon Re-Angioplasty for Treatment of Patients with Intra-Des Restenosis.

Detailed description

This is a prospective, randomized study to be conducted at up to 33 sites in France with 3 groups of patients (1 group with intra-Taxus™ restenosis, 1 group with intra-Cypher™ restenosis and 1 control group with intra-BMS restenosis). All patients will have a repeat angiography at 9 to 12 months post-procedure and will be followed up to 12 months post-procedure.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	drug-eluting stent and balloon angioplasty	CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
DEVICE	drug-eluting stent and balloon angioplasty	CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
DEVICE	drug-eluting stent	CYPHER Select ™ Sirolimus-eluting Stent

Timeline

• Start date: 2006-03-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2006-05-10
• Last updated: 2010-07-29

Locations

2 sites across 1 country: France