Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-04 @ 10:30 PM
Study NCT ID:
NCT03809494
Status:
TERMINATED
Last Update Posted:
2020-12-02
First Post:
2019-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HemaTrate™ in the Treatment of Critical Limb Ischemia
Sponsor:
Cook Research Incorporated
Organization:
Study Overview
Official Title:
Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study has stopped early due to enrollment challenges related largely to the current pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia. The primary endpoint measure is comparing the percentage of patients between the treatment arm and control arm who have freedom from major amputation, arterial intervention below the knee, and death through 12 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: