Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-30 @ 3:48 PM
Study NCT ID:
NCT04371861
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2020-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study to Assess Transradial Access for Treatment in the Lower Extremities.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-08-08', 'releaseDate': '2024-02-29'}, {'resetDate': '2025-09-25', 'releaseDate': '2025-09-05'}], 'estimatedResultsFirstSubmitDate': '2024-02-29'}}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-06', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-04-29', 'lastUpdatePostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radial access site complications', 'timeFrame': 'Procedure', 'description': 'Rates of occurrence in complications associated with transradial access.'}, {'measure': 'Procedural Success', 'timeFrame': 'Procedure', 'description': 'Successful completion of intended procedure without access complications and without conversion to femoral access.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'This study is designed to collect data on the complication rates and procedural success of using a transradial access approach to treat peripheral lesions in the lower extremities of a real world population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects planned to undergo treatment of a lower extremity lesion via transradial artery access.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Rutherford Category 2-5\n* Subject scheduled for a transradial intervention to treat a lesion in the lower extremities.\n* Willing to sign consent and agree to follow-up requirements.\n\nExclusion Criteria:\n\n* Previous failed transradial access attempt\n* Presence of or planned dialysis fistula.\n* Planned amputation\n* Previous or planned transradial access intervention +/- 30 days\n* Radial artery diameter \\<2.5mm\n* No palpable radial artery\n* Established vasospastic disease\n* Known allergy to contrast that cannot be managed\n* Pregnant or lactating\n* Mentally incompetent or a prisoner\n* Currently participating in a clinical study that has not completed it's primary endpoint"}, 'identificationModule': {'nctId': 'NCT04371861', 'acronym': 'R2P Registry', 'briefTitle': 'Observational Study to Assess Transradial Access for Treatment in the Lower Extremities.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Terumo Medical Corporation'}, 'officialTitle': 'Prospective, Multi-center, Observational, Post-market Study to Assess the Safety and Procedural Success of Performing Transradial Access for Treatment of Atherosclerotic Lesions in the Lower Extremities.', 'orgStudyIdInfo': {'id': 'TIS2019-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment of lower extremity lesion via transradial access.', 'description': 'Interventions performed are standard of care for treatment of a peripheral lesion.', 'interventionNames': ['Device: Peripheral Artery Treatment']}], 'interventions': [{'name': 'Peripheral Artery Treatment', 'type': 'DEVICE', 'description': 'Peripheral lesions may be treated by any standard of care methods of treatment.', 'armGroupLabels': ['Treatment of lower extremity lesion via transradial access.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Northside Hospital', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '70503', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cardiovascular Institute of the South', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Hospital', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Sorin Medical, Inc.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '78640', 'city': 'Kyle', 'state': 'Texas', 'country': 'United States', 'facility': 'Ascension Seton Hays Hospital', 'geoPoint': {'lat': 29.98911, 'lon': -97.87723}}], 'overallOfficials': [{'name': 'Mehdi Shishehbor, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals, Cleveland, OH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Terumo Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-02-29', 'type': 'RELEASE'}, {'date': '2024-08-08', 'type': 'RESET'}, {'date': '2025-09-05', 'type': 'RELEASE'}, {'date': '2025-09-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Terumo Medical Corporation'}}}}