Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-07 @ 8:45 PM
Study NCT ID:
NCT04304105
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2020-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089802', 'term': 'Chronic Limb-Threatening 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'}, {'id': 'D007511', 'term': 'Ischemia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2020-03-09', 'studyFirstSubmitQcDate': '2020-03-09', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amputation Free Survival (AFS)', 'timeFrame': '12 months', 'description': 'Defined as freedom from major (above ankle) amputation and death'}], 'secondaryOutcomes': [{'measure': 'Minor Amputation', 'timeFrame': '12 months', 'description': 'Number of patients with below-ankle amputation of the index limb'}, {'measure': 'Change in Rutherford Classification', 'timeFrame': '6 months and 12 months', 'description': 'Defined as a change of one class or greater, as evaluated at 6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CLI'], 'conditions': ['Critical Limb Ischemia', 'Peripheral Artery Disease']}, 'referencesModule': {'references': [{'pmid': '37858666', 'type': 'BACKGROUND', 'citation': 'Powell RJ, Mullin CM, Clair DG, Shishehbor MH, Dua A. Comparison of Transcatheter Arterialization of Deep Veins to Standard of Care in Patients with No-Option Chronic Limb Threatening Ischemia. Ann Vasc Surg. 2024 Feb;99:50-57. doi: 10.1016/j.avsg.2023.08.010. Epub 2023 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.', 'detailedDescription': 'The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.\n\nThe study population is comprised of Rutherford 5 and 6 CLTI subjects who have hemodynamic evidence of severely diminished arterial inflow of a peripheral limb and:\n\n1. 2 revascularizations in the last 6 months that failed to resolve symptoms, OR\n2. have inadequate popliteal, tibial, or pedal revascularization target'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is comprised of Rutherford 5 and 6 CLTI subjects who have hemodynamic evidence of severely diminished arterial inflow of a peripheral limb and:\n\n1. 2 revascularizations in the last 6 months that failed to resolve symptoms, OR\n2. have inadequate popliteal, tibial, or pedal revascularization target', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject must be ≥18 years of age\n2. Subject is Rutherford 5 or 6 classification with hemodynamic evidence of severely diminished arterial inflow of a peripheral limb and: a) 2 revascularizations in the last 6 months that failed to resolve symptoms, OR b) An inadequate popliteal, tibial, or pedal revascularization target\n3. Subject is willing and able to sign the informed consent form and willing to participate in the phone follow-ups.\n\nExclusion Criteria:\n\n1. Any significant concurrent psychological or social condition (e.g., no support person/network), which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.\n2. Subject is participating in the PROMISE II Clinical Trial."}, 'identificationModule': {'nctId': 'NCT04304105', 'briefTitle': 'Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'LimFlow, Inc.'}, 'officialTitle': 'Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study', 'orgStudyIdInfo': {'id': 'LF-CA-PR-8'}}, 'contactsLocationsModule': {'locations': [{'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "LA Foot & Ankle Clinic - St. Vincent's Hospital", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90501', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor- UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80205', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Veterans Affairs Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'The Cardiac and Vascular Institute', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '50266', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Unity Point Health', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '70065', 'city': 'Kenner', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.99409, 'lon': -90.24174}}, {'zip': '20782', 'city': 'Hyattsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar D.C.', 'geoPoint': {'lat': 38.95594, 'lon': -76.94553}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ascension St. John Detroit', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Lukes Mid America', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '27518', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'APCNC (Wake Med)', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina University (ECU, Vidant Medical)', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Coastal Carolina Surgical', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Anderson Heart and Vascular', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Vascular and Vein Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Seton Heart Institute', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78727', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Radiological Association', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'UT-San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'VCU, Virginia Commonwealth University Health System', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '00716', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'San Lucas Hospital', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LimFlow, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}