Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-25 @ 4:15 AM
Study NCT ID:
NCT03898869
Status:
UNKNOWN
Last Update Posted:
2019-04-02
First Post:
2019-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Revascularization Effect Using NIRS in BTK Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-29', 'studyFirstSubmitDate': '2019-03-29', 'studyFirstSubmitQcDate': '2019-03-29', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in oxygen amount sufficient for wound healing', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Detection of early recoil after BTK revascularization', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Percutaneous Transluminal Angioplasty', 'Wound Heal', 'Ischemic Feet']}, 'descriptionModule': {'briefSummary': 'Patient with occluded below the knee arteries and chronic limb ischemia Rutherford class V-VI are enrolled.\n\nDuring endovascular recanalisation procedure changes in tissue oxygen amount is recorded using near infrared spectroscopy (NIRS).\n\nPrimary hypothesis - NIRS can be used to determine sufficient amount of blood reaching the ulcered ishemic area.\n\nSecondary hypothesis - NIRS can be useful in detecting early recoil after BTK recanalisation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All-comers meeting eligibility criteria in VMK hospital, Vascular surgery department.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critical limb ischemia Rutherford V-VI\n* At least one artery below the knee is planned to revascularize\n\nExclusion Criteria:\n\n* Blood oxygen saturation below 85% because of any comorbidities\n* Life expectancy less than 12 months\n* Unavoidable amputation above ankle\n* Skin diseases preventing the use of NIRS'}, 'identificationModule': {'nctId': 'NCT03898869', 'briefTitle': 'Measurement of Revascularization Effect Using NIRS in BTK Arteries', 'organization': {'class': 'OTHER', 'fullName': 'Vilnius University'}, 'officialTitle': 'Measurement of Revascularization Effect Using Near Infrared Spectroscopy in Below the Knee Arteries', 'orgStudyIdInfo': {'id': 'BTK-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intraoperative NIRS monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': 'Near infrared spectroscopy non invasively used to register changes in tissue oxygen amount during endovascular revascularization'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LT-10207', 'city': 'Vilnius', 'status': 'RECRUITING', 'country': 'Lithuania', 'contacts': [{'name': 'Tomas Baltrūnas', 'role': 'CONTACT'}], 'facility': 'Vilniaus Miesto Klinikinė hospital', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}], 'centralContacts': [{'name': 'Tomas Baltrūnas', 'role': 'CONTACT', 'email': 'tomas.baltrunas@gmail.com', 'phone': '+37052344519'}], 'overallOfficials': [{'name': 'Tomas Baltrūnas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vilnius University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vilnius University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Tomas Baltrūnas', 'investigatorFullName': 'Tomas Baltrūnas', 'investigatorAffiliation': 'Vilnius University'}}}}