Status:
TERMINATED
HemaTrate™ in the Treatment of Critical Limb Ischemia
Lead Sponsor:
Cook Research Incorporated
Conditions:
Critical Limb Ischemia
Ischemia
Eligibility:
All Genders
18-85 years
Phase:
NA
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 p...
Eligibility Criteria
Inclusion
- Critical Limb Ischemia in the study leg with ischemic rest pain and/or ulcer/minor tissue loss (Rutherford 4 or 5)
- Previously failed an endovascular or surgical treatment of the study lower leg and is not being considered for additional intervention within the next 3 months OR is unsuitable for revascularization
Exclusion
- Simultaneously participating in another investigational study (e.g., drug or device)
- Pregnant or breastfeeding, or planning to become pregnant within the next 12 months
- Major surgery (open cardiac, vascular, or abdominal procedure) within the past 90 days
- Endovascular intervention within the past 30 days
- Current dialysis, or expected to need dialysis within the next 12 months
- Previous above the ankle amputation in the study leg
Key Trial Info
Start Date :
July 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03809494
Start Date
July 23 2019
End Date
November 27 2020
Last Update
December 2 2020
Active Locations (3)
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1
Manchester Royal Infirmary, Manchester Vascular Centre
Manchester, Great Britian, United Kingdom, M13 9WL
2
The Leeds Teaching Hospital NHS Trust
Leeds, West Yorkshire, United Kingdom, LS9 7TF
3
St Thomas' Hospital
London, United Kingdom, SE1 7EH