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出境医 / 临床实验 / HemaTrate™ in the Treatment of Critical Limb Ischemia

HemaTrate™ in the Treatment of Critical Limb Ischemia

Study Description
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.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Ischemia Device: HemaTrate™ Blood Filtration system Other: Saline Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Primary Purpose: Treatment
Official Title: Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia
Actual Study Start Date : July 23, 2019
Actual Primary Completion Date : November 27, 2020
Actual Study Completion Date : November 27, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Treatment Arm
Patients assigned to the treatment arm will be injected with autologous concentrated total nucleated cells (TNCs) three times at six week intervals.
 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.
Placebo Comparator: Saline (Control Arm)
Patients assigned to the control arm will be injected with saline three times at six week intervals.
 Other: Saline
Normal (0.9%) saline
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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

  3. Death [ Time Frame: 12 months ]
    Percent of patients that exit due to death


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
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United Kingdom
Manchester Royal Infirmary, Manchester Vascular Centre
Manchester, Great Britian, United Kingdom, M13 9WL
The Leeds Teaching Hospital NHS Trust
Leeds, West Yorkshire, United Kingdom, LS9 7TF
St Thomas' Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Cook Research Incorporated
Investigators
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Study Chair: Bijan Modarai, PhD, FRCS St Thomas' Hospital
Study Chair: Václav Procházka, MD, PhD, MSc University Hospital Ostrava
Study Chair: Giulio Pompilio, MD, PhD Centro Cardiologico Monzino IRCCS
Tracking Information
First Submitted Date  ICMJE January 16, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date December 2, 2020
Actual Study Start Date  ICMJE July 23, 2019
Actual Primary Completion Date November 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
  • 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
  • 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
  • Death [ Time Frame: 12 months ]
    Percent of patients that exit due to death
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HemaTrate™ in the Treatment of Critical Limb Ischemia
Official Title  ICMJE Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Primary Purpose: Treatment
Condition  ICMJE
  • Critical Limb Ischemia
  • Ischemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Treatment Arm
    Patients assigned to the treatment arm will be injected with autologous concentrated total nucleated cells (TNCs) three times at six week intervals.
    Intervention: Device: HemaTrate™ Blood Filtration system
  • Placebo Comparator: Saline (Control Arm)
    Patients assigned to the control arm will be injected with saline three times at six week intervals.
    Intervention: Other: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 30, 2020) 		2
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2019) 		350
Actual Study Completion Date  ICMJE November 27, 2020
Actual Primary Completion Date November 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries Czechia,   Poland
 
Administrative Information
NCT Number  ICMJE NCT03809494
Other Study ID Numbers  ICMJE 15-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Responsible Party Cook Group Incorporated ( Cook Research Incorporated )
Study Sponsor  ICMJE Cook Research Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Bijan Modarai, PhD, FRCS St Thomas' Hospital
Study Chair: Václav Procházka, MD, PhD, MSc University Hospital Ostrava
Study Chair: Giulio Pompilio, MD, PhD Centro Cardiologico Monzino IRCCS
PRS Account Cook Group Incorporated
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP