Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT04710420
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2021-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With Wound, Ischemia, and Foot Infection (WIFI) Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'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': 842}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-08', 'studyFirstSubmitDate': '2021-01-08', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from major amputation', 'timeFrame': '12 months', 'description': 'Major amputation was defined as any amputation above-the-ankle of the target limb.'}], 'secondaryOutcomes': [{'measure': 'WIfI stages', 'timeFrame': '12 months', 'description': 'Before follow-up and during each follow-up, the Society for Vascular Surgery wound, ischemia, and foot Infection (WIfI) were evaluated classification system.'}, {'measure': 'Amputation-free survival', 'timeFrame': '12 months', 'description': 'Survival without target limb major amputation.'}, {'measure': 'Freedom from all-cause death', 'timeFrame': '12 months', 'description': 'Freedom from all-cause death.'}, {'measure': 'Freedom from clinically driven target limb reintervention', 'timeFrame': '12 months', 'description': 'Clinically driven target limb reintervention was defined as any reintervention of ipsilateral infrapopliteal arteries for recurrent clinical symptoms.'}, {'measure': 'Freedom from major adverse event', 'timeFrame': '12 months', 'description': 'Major adverse event was a composite of major amputation, all-cause death, and clinically driven target limb reintervention.'}, {'measure': 'Quality of life', 'timeFrame': '12 months', 'description': 'The Vascular Quality of Life (VascuQol) questionnaire was used to assess QOL score.'}, {'measure': 'Primary sustained clinical improvement', 'timeFrame': '12 months', 'description': 'A decrease of at least 1 Rutherford grade without any reintervention.'}, {'measure': 'Hospitalization time', 'timeFrame': '12 months', 'description': 'The length of hospital stay was evaluated'}, {'measure': 'Hospitalization expenses', 'timeFrame': '12 months', 'description': 'Hospitalization costs for patients were evaluated'}, {'measure': 'Adverse event rates', 'timeFrame': '1 week', 'description': 'Adverse event rates includes surgically related arterial dissection, perforation, rupture, embolism, acute thrombosis, pseudoaneurysm and hematoma formation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Limb-threatening Ischemia', 'Endovascular Therapy']}, 'descriptionModule': {'briefSummary': 'This is a prospective multicenter clinical study that used WIFI grading scores at different periods to evaluate the therapeutic value of endovascular therapy and this grading system for Chronic limb-threatening ischemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Chronic limb-threatening ischemia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients \\> 18 years of age;\n2. patients with Chronic limb-threatening ischemia (CLTI);\n3. patients with below-the-knee lesions undergoing endovascular treatment;\n4. target limbs with certain WIfI stage;\n5. patients voluntary and capable of follow-up;\n6. informed consent.\n\nDefinition of CLTI:\n\nA diagnosis of CLTI requires objectively documented atherosclerotic PAD in association with ischemic rest pain or tissue loss (ulceration or gangrene).\n\nExclusion Criteria:\n\n1. Contraindication for antiplatelet , anticoagulant or thrombolytic agent;\n2. Contrast agent allergy;\n3. Dysfunctional protein C, protein S, antithrombin Ⅲ(AT Ⅲ) or refusal of blood transfusion;\n4. Complications affecting surgical safety;\n5. Major amputation was adopted to the target extremity;\n6. The existence of aneurysm in the target vessels;\n7. The existence of perforation, dissection or any other injury requiring intervention in the target vessels.'}, 'identificationModule': {'nctId': 'NCT04710420', 'briefTitle': 'Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With Wound, Ischemia, and Foot Infection (WIFI) Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With WIFI Assessment', 'orgStudyIdInfo': {'id': 'PRIME-WIFI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'WIfI stage 1', 'description': 'Very low risk of amputation was determined according to the SVS WIfI classification system.', 'interventionNames': ['Device: Endovascular therapy']}, {'label': 'WIfI stage 2', 'description': 'Low risk of amputation was determined according to the SVS WIfI classification system.', 'interventionNames': ['Device: Endovascular therapy']}, {'label': 'WIfI stage 3', 'description': 'Moderate risk of amputation was determined according to the SVS WIfI classification system.', 'interventionNames': ['Device: Endovascular therapy']}, {'label': 'WIfI stage 4', 'description': 'High risk of amputation was determined according to the SVS WIfI classification system.', 'interventionNames': ['Device: Endovascular therapy']}], 'interventions': [{'name': 'Endovascular therapy', 'type': 'DEVICE', 'description': 'Endovascular treatment for critical limb threatening Ischemia', 'armGroupLabels': ['WIfI stage 1', 'WIfI stage 2', 'WIfI stage 3', 'WIfI stage 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xuanwu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'collaborators': [{'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Soochow University', 'class': 'OTHER'}, {'name': 'Qingdao Haici Hospital', 'class': 'OTHER'}, {'name': 'Hospital of Chengdu University of Traditional Chinese Medicine', 'class': 'UNKNOWN'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'Huashan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, vascular suregry department', 'investigatorFullName': 'Lian-Rui Guo', 'investigatorAffiliation': 'Xuanwu Hospital, Beijing'}}}}