Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Critical Limb Ischemia
- Sponsor
- Cook Research Incorporated
- Enrollment
- 2
- Locations
- 3
- Primary Endpoint
- Freedom from vascular or endovascular arterial intervention below the knee of the study leg
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Freedom from vascular or endovascular arterial intervention below the knee of the study leg
Time Frame: 12 months
Percent of patients that have vascular or endovascular arterial intervention reported below the knee of the study leg
Death
Time Frame: 12 months
Percent of patients that exit due to death
Freedom from major amputation of the study leg
Time Frame: 12 months
Percent of patients that have any amputation above the ankle of the study leg