Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT04974905
Status:
UNKNOWN
Last Update Posted:
2021-07-23
First Post:
2021-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-15', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety of retrograde approach as regard occurrence of procedure specific complications', 'timeFrame': 'within one year of follow up', 'description': 'safety of retrograde approach after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease, in the light of complications which are classified into major or minor according to the reporting standards of society of vascular surgery.this complications will be looked for and data will be collected'}, {'measure': 'feasibility of retrograde approach as regard successful retrograde puncture and technical success after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease.', 'timeFrame': 'within one year of follow up', 'description': 'it means that this approach can be used successfuly in clinical practice and this will be assessd by measuring successful retrograde puncture and technical success.\n\nsuccessful retrograde puncture means successful performance of retrograde puncture at any of the retrograde distal puncture sites with intraluminal placement of the retrograde guidewire confirmed by contrast angiography without causing procedure specific complications namely local dissection, rupture, or an arteriovenous fistula at puncture site.\n\ntechnical success is defined as successful puncture followed by successful crossing of the occlusion and regain of inline flow to the foot with less than 30%residual stenosis after treatment.'}], 'secondaryOutcomes': [{'measure': 'clinical success of the procedure', 'timeFrame': 'within one year of follow up', 'description': 'immediate clinical success is defined as regain of distal pulses, revascularization warmness and edema, and/or disappearance of rest pain.'}, {'measure': 'One year limb salvage rate of the procedure', 'timeFrame': 'within one year of follow up', 'description': 'limb salvage is defined as healing of existing wounds with no amputation proximal to metatarsus.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Limb Ischemia']}, 'referencesModule': {'references': [{'pmid': '31834669', 'type': 'BACKGROUND', 'citation': 'Mustapha JA, Saab F, McGoff TN, Adams G, Mullins JR, Al-Dadah A, Jaff MR, Goodney PP, Khawaja F, Diaz-Sandoval LJ. Tibiopedal arterial minimally invasive retrograde revascularization (TAMI) in patients with peripheral arterial disease and critical limb ischemia. On behalf of the Peripheral Registry of Endovascular Clinical Outcomes (PRIME). Catheter Cardiovasc Interv. 2020 Feb 15;95(3):447-454. doi: 10.1002/ccd.28639. Epub 2019 Dec 13.'}, {'pmid': '25241321', 'type': 'BACKGROUND', 'citation': 'Hendricks NJ, Sabri SS. Subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) and rertograde access for critical limb ischemia. Tech Vasc Interv Radiol. 2014 Sep;17(3):203-10. doi: 10.1053/j.tvir.2014.08.009. Epub 2014 Sep 4.'}, {'pmid': '24650744', 'type': 'BACKGROUND', 'citation': 'Bazan HA, Le L, Donovan M, Sidhom T, Smith TA, Sternbergh WC 3rd. Retrograde pedal access for patients with critical limb ischemia. J Vasc Surg. 2014 Aug;60(2):375-81. doi: 10.1016/j.jvs.2014.02.038. Epub 2014 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'The spectrum of lower extremity peripheral arterial disease (PAD) ranges from exhibiting no symptoms to limb threatening gangrene. The number of patients living with it is rising steadily owing to increased life expectancy, obesity, diabetes, and tobacco consumption.\n\nCritical limb ischemia (CLI) is the terminal and the most serious stage of PAD in which blood flow to the lower extremity does not meet metabolic demands of the tissues at rest. The diagnosis is mainly clinical and patients are presented with rest pain, minimal tissue loss or frank gangrene.\n\nRevascularization strategies include endovascular procedures and surgical bypass.Endovascular therapy has evolved as an attractive, minimally invasive method of revascularization especially in the more frequently encountered patients with medical and anatomical contraindications to surgical revascularization.\n\nAntegrade approach is the standard approach in infrainguinal arterial occlusive disease,however, failure occurs in about 20% of infrainguinal attempts.Retrograde approach is used as a backup technique in failed cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients with;\n\n1. CLI consistent with Rutherford categories (4-5).\n2. Infrainguinal arterial occlusive disease with a patent distal part of at least one tibial vessel runoff to the foot.\n\nExclusion Criteria:\n\npatients with the following conditions will be excluded:\n\n1. Non-salvageable limbs.\n2. Life threatening infections requiring major amputation.\n3. Ulcers at the area of intended puncture.'}, 'identificationModule': {'nctId': 'NCT04974905', 'briefTitle': 'Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Retrograde Approach for Management of Infrainguinal Arterial Occlusive Disease After Failed Antegrade Approach in Critical Limb Ischemia Patients; Feasibility, Safety, and Procedure Related Outcomes.', 'orgStudyIdInfo': {'id': 'Soh-Med-21-07-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'patients with infrainguinal arterial occlusive disease after failed antegrade approach', 'interventionNames': ['Procedure: retrograde access for re-canalization of infra-inguinal arterial occlusive disease']}], 'interventions': [{'name': 'retrograde access for re-canalization of infra-inguinal arterial occlusive disease', 'type': 'PROCEDURE', 'description': 'after failed antegrade approach for re-canalization of infra-inguinal arterial occlusive disease( failed reentry into the distal true lumen), the retrograde approach will be attempted', 'armGroupLabels': ['patients with infrainguinal arterial occlusive disease after failed antegrade approach']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mostafa A Foda, Msc', 'role': 'CONTACT', 'email': 'm_foda_revolution2020@yahoo.com', 'phone': '01012514518'}, {'name': 'Hussein K Hussein, Professor', 'role': 'CONTACT', 'phone': '01222142667'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer in the department of vascular surgery', 'investigatorFullName': 'Mostafa Abdelmagied Ragb Fouda', 'investigatorAffiliation': 'Sohag University'}}}}