Critical Limb Ischemia, Ischemia
Conditions
Keywords
lower extremity, Peripheral Arterial Disease, Ischemia, Peripheral Blood Stem Cell Transplantation, Leukocytes, Mononuclear, Transplantation, Autologous
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.
Interventions
DEVICEHemaTrate™ Blood Filtration system
Anticoagulated whole blood is loaded into the filtration system. During gravity filtration, the majority of platelets, plasma, and red blood cells pass through the filter into a filtrate bag. The TNCs are captured in the filter material and recovered via a back-flush with 0.9 % saline into a syringe.
OTHERSaline
Normal (0.9%) saline
Sponsors
Cook Research Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The investigator for this study is the person that will be performing the injections throughout the study and will know the participant's treatment (TNC or saline). The investigator that is aware of the participant's treatment will not be performing the follow-up visits.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Critical Limb Ischemia in the study leg with ischemic rest pain and/or ulcer/minor tissue loss (Rutherford 4 or 5) 2. 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
1. Simultaneously participating in another investigational study (e.g., drug or device) 2. Pregnant or breastfeeding, or planning to become pregnant within the next 12 months 3. Major surgery (open cardiac, vascular, or abdominal procedure) within the past 90 days 4. Endovascular intervention within the past 30 days 5. Current dialysis, or expected to need dialysis within the next 12 months 6. Previous above the ankle amputation in the study leg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from vascular or endovascular arterial intervention below the knee of the study leg | 12 months | Percent of patients that have vascular or endovascular arterial intervention reported below the knee of the study leg |
| Freedom from major amputation of the study leg | 12 months | Percent of patients that have any amputation above the ankle of the study leg |
| Death | 12 months | Percent of patients that exit due to death |
Countries
United Kingdom
Outcome results
None listed