Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00485004
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2007-06-11
Brief Title:
Focal In-stent Restenosis After Drug-Eluting Stent
Sponsor:
Seung-Jung Park
Organization:
CardioVascular Research Foundation Korea
Study Overview
Official Title:
FOcal Type In-stent Restenosis After Drug-Eluting Stent Implantation Treated by CUtting Balloon Angioplasty Versus Sirolimus-Eluting Stent
Status:
COMPLETED
Status Verified Date:
2012-08
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:
FOCUS
Brief Summary:
To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty
Detailed Description:
Following angiography patients with focal DES restenosis lesion length 10mm with diameter stenosis 50 by visual estimation have documented myocardial ischemia or symptoms of angina and eligible for PCI without any exclusion criteria will be randomized 11 to a Cypher stent vs b Cutting balloon angioplasty All patients will be followed for 1 year Angiographic follow-up at 9-months is mandatory
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