Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492733
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-01
Brief Title:
FastWire REvascularisation of Extremities For LOWer Limbs - FREEFLOW
Sponsor:
Redacted
Organization:
Redacted
Study Overview
Official Title:
A Pivotal Single-arm Multi-centre Prospective Clinical Investigation to Assess the Efficacy and Safety of the FastWire REvascularisation of Extremities For LOWer Limbs FREEFLOW
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
True
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to assess the safety and efficacy of the FastWire System It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions CTOs
Detailed Description:
Single-arm multi-center pivotal study to assess the efficacy and safety of the FastWire System in patients who have a chronic total occlusion in their peripheral vasculature causing an ischemic limb The enrollment will consist of up to 65 patients meeting the inclusionexclusion criteria
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