Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-01-02 @ 6:31 AM
Study NCT ID:
NCT00485004
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2007-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focal In-stent Restenosis After Drug-Eluting Stent
Sponsor:
Seung-Jung Park
Organization:
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 1:1 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:
True
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?: