Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-04 @ 10:30 PM
Study NCT ID:
NCT03809494
Status:
TERMINATED
Last Update Posted:
2020-12-02
First Post:
2019-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HemaTrate™ in the Treatment of Critical Limb Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia', 'Poland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "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."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'The study has stopped early due to enrollment challenges related largely to the current pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-30', 'studyFirstSubmitDate': '2019-01-16', 'studyFirstSubmitQcDate': '2019-01-16', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from vascular or endovascular arterial intervention below the knee of the study leg', 'timeFrame': '12 months', 'description': 'Percent of patients that have vascular or endovascular arterial intervention reported below the knee of the study leg'}, {'measure': 'Freedom from major amputation of the study leg', 'timeFrame': '12 months', 'description': 'Percent of patients that have any amputation above the ankle of the study leg'}, {'measure': 'Death', 'timeFrame': '12 months', 'description': 'Percent of patients that exit due to death'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lower extremity', 'Peripheral Arterial Disease', 'Ischemia', 'Peripheral Blood Stem Cell Transplantation', 'Leukocytes, Mononuclear', 'Transplantation, Autologous'], 'conditions': ['Critical Limb Ischemia', 'Ischemia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Critical Limb Ischemia in the study leg with ischemic rest pain and/or ulcer/minor tissue loss (Rutherford 4 or 5)\n2. 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\n\nExclusion Criteria:\n\n1. Simultaneously participating in another investigational study (e.g., drug or device)\n2. Pregnant or breastfeeding, or planning to become pregnant within the next 12 months\n3. Major surgery (open cardiac, vascular, or abdominal procedure) within the past 90 days\n4. Endovascular intervention within the past 30 days\n5. Current dialysis, or expected to need dialysis within the next 12 months\n6. Previous above the ankle amputation in the study leg'}, 'identificationModule': {'nctId': 'NCT03809494', 'briefTitle': 'HemaTrate™ in the Treatment of Critical Limb Ischemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia', 'orgStudyIdInfo': {'id': '15-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'Patients assigned to the treatment arm will be injected with autologous concentrated total nucleated cells (TNCs) three times at six week intervals.', 'interventionNames': ['Device: HemaTrate™ Blood Filtration system']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline (Control Arm)', 'description': 'Patients assigned to the control arm will be injected with saline three times at six week intervals.', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'HemaTrate™ Blood Filtration system', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Treatment Arm']}, {'name': 'Saline', 'type': 'OTHER', 'description': 'Normal (0.9%) saline', 'armGroupLabels': ['Saline (Control Arm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9WL', 'city': 'Manchester', 'state': 'Great Britian', 'country': 'United Kingdom', 'facility': 'Manchester Royal Infirmary, Manchester Vascular Centre', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'The Leeds Teaching Hospital NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': "St Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Bijan Modarai, PhD, FRCS', 'role': 'STUDY_CHAIR', 'affiliation': "St Thomas' Hospital"}, {'name': 'Václav Procházka, MD, PhD, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Ostrava'}, {'name': 'Giulio Pompilio, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centro Cardiologico Monzino IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Research Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}