HemaTrate™ in the Treatment of Critical Limb Ischemia

Not Applicable

Terminated

• Conditions: Ischemia; Critical Limb Ischemia
• Interventions: Other: Saline; Device: HemaTrate™ Blood Filtration system

• Registration Number: NCT03809494
• Lead Sponsor: Cook Research Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-16
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-18
• Study Start: 2019-07-23
• Status Verified: 2020-11
• Primary Completion: 2020-11-27
• Study Completion: 2020-11-27
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline (Control Arm)	Saline	Patients assigned to the control arm will be injected with saline three times at six week intervals.
Treatment Arm	HemaTrate™ Blood Filtration system	Patients assigned to the treatment arm will be injected with autologous concentrated total nucleated cells (TNCs) three times at six week intervals.

Primary Outcome Measures

Name	Time	Method
Freedom from major amputation of the study leg	12 months	Percent of patients that have any amputation above the ankle of the study leg
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
Death	12 months	Percent of patients that exit due to death

Trial Locations

Locations (3)

The Leeds Teaching Hospital NHS Trust; 🇬🇧 Leeds, West Yorkshire, United Kingdom

Manchester Royal Infirmary, Manchester Vascular Centre; 🇬🇧 Manchester, Great Britian, United Kingdom

St Thomas' Hospital; 🇬🇧 London, United Kingdom