Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156624
Status:
UNKNOWN
Last Update Posted:
2006-04-25
First Post:
2005-09-07
Brief Title:
Thunder Trial - Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries Thunder - Trial
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
The Thunder Trail is a randomized double-blinded placebo controlled German multi-centre study on the efficacy of local paclitaxel for prevention of restenosis in the superficial and popliteal artery
Detailed Description:
Drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries Unfortunately drug eluting stents failed to demonstrate superiority over bare stents in the superficial femoral artery We could show that a non-stent based delivery of Taxan was equal or superior to drug eluting stents in an animal model This was both true for the coronary arteries and peripheral vessels
In a prospective blinded trail 135 patients are randomized either to receive Taxan locally administered with a balloon catheter during balloon angioplasty or together with contrast media One group serves as control There were no limitations due to lesion length Follow-up angiography will be after 6 months 12 months and 2 years
In a prospective blinded trail 135 patients are randomized either to receive Taxan locally administered with a balloon catheter during balloon angioplasty or together with contrast media One group serves as control There were no limitations due to lesion length Follow-up angiography will be after 6 months 12 months and 2 years
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