Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT04304105
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2020-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
Sponsor:
LimFlow, Inc.
Organization:
Study Overview
Official Title:
Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
Status:
COMPLETED
Status Verified Date:
2024-11
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:
None
Brief Summary:
The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.
Detailed Description:
The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.
The study population is comprised of Rutherford 5 and 6 CLTI subjects who have hemodynamic evidence of severely diminished arterial inflow of a peripheral limb and:
1. 2 revascularizations in the last 6 months that failed to resolve symptoms, OR
2. have inadequate popliteal, tibial, or pedal revascularization target
The study population is comprised of Rutherford 5 and 6 CLTI subjects who have hemodynamic evidence of severely diminished arterial inflow of a peripheral limb and:
1. 2 revascularizations in the last 6 months that failed to resolve symptoms, OR
2. have inadequate popliteal, tibial, or pedal revascularization target
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?: