Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-04-14 @ 5:17 AM
Study NCT ID:
NCT04323033
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2019-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Peripheral, Cobalt-chromium Sirolimus Eluting Stent (PERS) Versus Cobalt-chromium Stent (Neptune C)
Sponsor:
Balton Sp.zo.o.
Organization:
Study Overview
Official Title:
Prospective, Randomized Clinical Trial Evaluating Safety and Efficacy of Cobalt-chromium Sirolimus Eluting Stent (PERS) by Balton Versus Cobalt-chromium Stent (Neptune C), to Maintain Patency of Iliac Arteries in Patients Undergoing Peripheral Angioplasty
Status:
COMPLETED
Status Verified Date:
2022-03
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:
PERS
Brief Summary:
The aim of this study is to assess the safety and efficacy of PAD treatment by revascularization with new cobalt-chromium sirolimus stent implantation, which is expandable on balloon PERS (CoCr SES) compared to cobalt-chromium balloon-expandable (Neptun C) stent (CoCr BMS) in patients with symptomatic iliac arteries disease requiring revascularization.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: