HemaTrate™ in the Treatment of Critical Limb Ischemia

Critical Limb Ischemia Clinical Trial

Official title:

Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03809494
• Other study ID #: 15-03
• Status: Terminated
• Phase: N/A
• Start date: July 23, 2019
• Est. completion date: November 27, 2020

Study information

• Verified date: November 2020
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 27, 2020
• Est. primary completion date: November 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

Device:
• HemaTrate™ 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.

Other:
• Saline
Normal (0.9%) saline

Locations

Country	Name	City	State
United Kingdom	The Leeds Teaching Hospital NHS Trust	Leeds	West Yorkshire
United Kingdom	St Thomas' Hospital	London
United Kingdom	Manchester Royal Infirmary, Manchester Vascular Centre	Manchester	Great Britian

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from vascular or endovascular arterial intervention below the knee of the study leg	Percent of patients that have vascular or endovascular arterial intervention reported below the knee of the study leg	12 months
Primary	Freedom from major amputation of the study leg	Percent of patients that have any amputation above the ankle of the study leg	12 months
Primary	Death	Percent of patients that exit due to death	12 months