Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410313
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-01
Brief Title:
First in Human Study to Assess Safety and Efficacy of the ChampioNIR Drug Eluting Peripheral Stent in the Treatment of Patients with Superficial Femoral Artery Disease Andor Proximal Popliteal Artery Disease
Sponsor:
Medinol Ltd
Organization:
Medinol Ltd
Study Overview
Official Title:
First in Human Study to Assess Safety and Efficacy of the ChampioNIR Drug Eluting Peripheral Stent in the Treatment of Patients with Superficial Femoral Artery Disease Andor Proximal Popliteal Artery Disease
Status:
RECRUITING
Status Verified Date:
2024-09
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:
CHAMPIONSHIP
Brief Summary:
This is a prospective open label multicenter single arm first in human clinical study
Patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be enrolled The patients will be treated with the ChampioNIR Stent System All implanted patients will be followed up at 30 days and 6 12 24 and 36 months The follow-up visits will include patency evaluation by duplex ultrasound
Patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be enrolled The patients will be treated with the ChampioNIR Stent System All implanted patients will be followed up at 30 days and 6 12 24 and 36 months The follow-up visits will include patency evaluation by duplex ultrasound
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None