Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323895
Status:
COMPLETED
Last Update Posted:
2010-07-29
First Post:
2006-05-09
Brief Title:
The Intra-Drug Eluting Stent DES Restenosis Study
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
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
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRISTAL
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None