Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-03-22 @ 2:33 PM
Study NCT ID:
NCT02033135
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2014-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis (PESETA)
Status:
UNKNOWN
Status Verified Date:
2014-01
Last Known Status:
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:
PESETA
Brief Summary:
This randomized clinical study is intended to evaluate the use of Zilver PTX stents for treatment of thigh atherosclerosis.
Research question: Is there an adjuvant benefit of angioplasty and stenting using the new paclitaxel eluting stent, Zilver-PTX, over risk factor modification and medical therapy alone in patients with stable, mild to moderate intermittent claudication caused by femoropopliteal lesions suitable for endovascular management.
Research question: Is there an adjuvant benefit of angioplasty and stenting using the new paclitaxel eluting stent, Zilver-PTX, over risk factor modification and medical therapy alone in patients with stable, mild to moderate intermittent claudication caused by femoropopliteal lesions suitable for endovascular management.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: