Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-02 @ 1:34 AM
Study NCT ID:
NCT04356092
Status:
COMPLETED
Last Update Posted:
2020-04-22
First Post:
2020-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '2D-perfusion imaging and analysis of the DICOM files was performed after revascularization, by an investigator blinded to the name of the patient or the result of the angioplasty procedure. The participant was also blinded to the results of the perfusion outcomes during follow up.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'In total, 7 consecutive patients were included in the study. The 2D-perfusion imaging and analysis of the DICOM files were performed after revascularization.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-18', 'studyFirstSubmitDate': '2020-04-15', 'studyFirstSubmitQcDate': '2020-04-18', 'lastUpdatePostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Perfusion Blood Volume (PBV)', 'timeFrame': 'Ten minutes before and five minutes after the intervention', 'description': 'PBV calculated on subtraction images and pre- and post-procedural values were compared using the proposed 2D perfusion DSA software.'}, {'measure': 'Change in Mean Transit Time (MTT)', 'timeFrame': 'Ten minutes before and five minutes after the intervention', 'description': 'MTT calculated on subtraction images and pre- and post-procedural values were compared using the proposed 2D perfusion DSA software.'}, {'measure': 'Change in Perfusion Blood Flow (PBF)', 'timeFrame': 'Ten minutes before and five minutes after the intervention', 'description': 'PBF calculated on subtraction images and pre- and post-procedural values compared using the proposed 2D perfusion DSA software.'}], 'secondaryOutcomes': [{'measure': 'Major amputation rate', 'timeFrame': 'Six months', 'description': 'The rate of above the knee target limb amputation'}, {'measure': 'Procedure-related complications', 'timeFrame': '30 days', 'description': 'Complications noted during and after the index procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infrapopliteal angioplasty', 'Tissue perfusion', 'Quantification'], 'conditions': ['Ischemia Limb']}, 'referencesModule': {'references': [{'pmid': '32875390', 'type': 'DERIVED', 'citation': 'Kagadis GC, Tsantis S, Gatos I, Spiliopoulos S, Katsanos K, Karnabatidis D. 2D perfusion DSA with an open-source, semi-automated, color-coded software for the quantification of foot perfusion following infrapopliteal angioplasty: a feasibility study. Eur Radiol Exp. 2020 Sep 2;4(1):47. doi: 10.1186/s41747-020-00176-z.'}]}, 'descriptionModule': {'briefSummary': 'A custom-made, 2D-perfusion digital subtraction angiography (PDSA) algorithm has been designed and implemented towards foot perfusion quantification following endovascular treatment of critical limb ischemia (CLI), in order to assist intra-procedural decision-making and enhance clinical outcomes.', 'detailedDescription': "This is a prospective, single-center, study investigating the feasibility of 2D-PDSA using newly-developed, non-commercially available, color-coded software for the quantification of foot perfusion following infrapopliteal angioplasty for the treatment of CLI. In total, 7 consecutive patients scheduled to undergo infrapopliteal endovascular treatment of CLI were enrolled. Perfusion Blood Volume (PBV), Mean Transit Time (MTT), and Perfusion Blood Flow (PBF) maps were extracted by analyzing Time-Intensity Curves and signal intensity on the perfused vessel mask. Mean values calculated from user-specified ROIs on perfusion maps were employed to evaluate the patient's pre- and post- endovascular treatment condition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients prescheduled for infrapopliteal angioplasty due to chronic limb-threatening ischemia.\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Image post-processing not feasible due to significant motion artifacts produced during DSA'}, 'identificationModule': {'nctId': 'NCT04356092', 'briefTitle': '2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty', 'organization': {'class': 'OTHER', 'fullName': 'Attikon Hospital'}, 'officialTitle': 'Feasibility of 2D Perfusion DSA With Custom-made, Color-coded Software for the Quantification of Foot Perfusion Following Infrapopliteal Angioplasty', 'orgStudyIdInfo': {'id': '264/12.04.2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Perfusion', 'description': 'Consecutive patients scheduled to undergo infrapopliteal angioplasty or stenting, or both, as part of their standard treatment for Rutherford-Becker class 5 and 6 chronic limb-threatening ischemia, were included in the study. All procedures were performed using local anesthesia. An antegrade access was used in all patients followed by the deployment of a 5 or 6 Fr arterial sheaths. A semi-lateral foot projection was preferred and the pre-revascularization DSA of the foot was performed via a 5 Fr angiographic catheter placed at the distal third of the popliteal artery. Following revascularization of one or more tibial arteries, the catheter was placed at the same popliteal segment and post-procedural DSA of the foot was performed following the exact pre-revascularization injection protocol at the same semi-lateral projection. The 2D-perfusion imaging and analysis of the DICOM files was performed after revascularization.', 'interventionNames': ['Diagnostic Test: 2D perfusion digital subtraction angiography of the foot.']}], 'interventions': [{'name': '2D perfusion digital subtraction angiography of the foot.', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Infrapopliteal angioplasty'], 'description': '2D perfusion digital subtraction angiography of the foot was performed after infrapopliteal angioplasty and Perfusion Blood Volume (PBV), Mean Transit Time (MTT), and Perfusion Blood Flow (PBF) maps were extracted by analyzing Time-Intensity Curves and signal intensity on the perfused vessel mask.', 'armGroupLabels': ['Perfusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26500', 'city': 'Pátrai', 'state': 'Achaia', 'country': 'Greece', 'facility': 'Patras University Hospital', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}], 'overallOfficials': [{'name': 'Dimitris Karnamatidis, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Patras University Hospital, Rion, Greece'}, {'name': 'George Kagadis, PhD, FAAPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Patras, Greece'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Attikon Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of Patras', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in Interventional Radiology', 'investigatorFullName': 'Stavros Spiliopoulos', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}