Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472472
Status:
COMPLETED
Last Update Posted:
2010-06-30
First Post:
2007-05-10
Brief Title:
Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries
Sponsor:
University Hospital Saarland
Organization:
University Hospital Saarland
Study Overview
Official Title:
Paclitaxel Coated Balloon Catheter for Inhibition of Restenosis in Femoropopliteal Arteries PACCOCATH - FEM I
Status:
COMPLETED
Status Verified Date:
2007-05
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:
PACCOCATH_F
Brief Summary:
The PACCOCATH FEM study is a randomized double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis after femoropopliteal angioplasty
Detailed Description:
Background Treatment of patients with peripheral arterial disease PAD in the femoropopliteal arteries by percutaneous intervention is still limited by high rates of restenosis The aim of the present study is to evaluate the efficacy and safety of a novel method of short time local drug delivery based on a paclitaxel-coated balloon in femoropopliteal arteries
Methods and results The double-blind and randomized study enrolled n79 patients with occlusion or stenosis of femoropopliteal arteries Inclusion criteria were clinical Rutherford stage 1-5 occlusion or hemodynamic relevant stenosis 70 diameter of femoropopliteal arteries and successful guiding wire recanalization The primary endpoint was the late lumen loss after 6 months follow-up as seen in angiography Secondary endpoints included the rate of restenosis a binary variable change of ankle brachial index ABI rutherford class and major adverse events
Methods and results The double-blind and randomized study enrolled n79 patients with occlusion or stenosis of femoropopliteal arteries Inclusion criteria were clinical Rutherford stage 1-5 occlusion or hemodynamic relevant stenosis 70 diameter of femoropopliteal arteries and successful guiding wire recanalization The primary endpoint was the late lumen loss after 6 months follow-up as seen in angiography Secondary endpoints included the rate of restenosis a binary variable change of ankle brachial index ABI rutherford class and major adverse events
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