Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605209
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Evaluation of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery StenosisOcclusion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multi-Center Non-Randomized Single-Arm Study Evaluating the Peripheral Balloon-Expandable Covered Stent System for the Treatment of Stenosis Andor Occlusive Lesions in the Common and External Iliac Arteries
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective multi-center single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis andor occlusion in the common and external iliac arteries The safety and effectiveness of the stent system will be compared to pre-set performance goals All treated subjects will have follow-up visits at discharge and at 1 6 12 24 and 36 months after the procedure
Detailed Description:
None
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