Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT05868161
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2023-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pounce™ Thrombectomy System Retrospective Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2023-04-06', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural Success', 'timeFrame': 'Peri-procedural (by the end of the index procedure)', 'description': 'Restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment as determined by the core lab and physician'}, {'measure': 'Incidence of device related Major Adverse Events (MAEs)', 'timeFrame': 'Procedure to 30 days', 'description': 'Death, Unplanned major amputation (above ankle), Clinically Driven target lesion revascularization (TLR)'}], 'secondaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'Peri-procedural (by the end of the index procedure)', 'description': 'Restoration of blood flow to the target lesion(s) with \\<50% residual thrombus without the need to initiate CDT or to proceed to open surgery or other endovascular thrombectomy device as determined by the core lab'}, {'measure': 'Completeness of thromboemboli removal (by angiography)', 'timeFrame': 'Peri-procedural (by the end of the index procedure)', 'description': 'Completeness of thromboemboli removal (by angiography) not including underlying atheroma as determined by the core lab and physician'}, {'measure': 'Thrombo-aspiration in Peripheral Interventions (TIPI) flow rate', 'timeFrame': 'Peri-procedural (by the end of the index procedure)', 'description': 'TIPI flow rate at the end of thrombectomy procedure and after any adjunctive procedures as determined by the core lab and physician.'}, {'measure': 'Modified Society for Vascular Surgery (SVS) runoff', 'timeFrame': 'Pre-procedure, Peri-procedural (by the end of the index procedure)', 'description': 'Pre-procedure vs. post-procedure runoff using a modified SVS runoff score as determined by the core lab and physician (if applicable).'}, {'measure': 'Underlying atheroma stenosis', 'timeFrame': 'Peri-procedural (by the end of the index procedure)', 'description': 'Length of underlying atheroma stenosis necessitating treatment compared to original lesion length as determined by the core lab and physician'}, {'measure': 'Describe index procedural characteristics', 'timeFrame': 'Peri-procedural (by the end of the index procedure)', 'description': 'Number of passes of Pounce Thrombectomy System\n\n* Total number of passes\n* Number of passes in each vessel'}, {'measure': 'Adjunctive procedures', 'timeFrame': 'Peri-procedural (by the end of the index procedure)', 'description': 'Percentage of subjects in whom adjunctive procedures were performed\n\n▪ Treatment for: underlying atheroma, residual thrombus, residual embolus, other'}, {'measure': 'Index procedure durations', 'timeFrame': 'Peri-procedural (by the end of the index procedure)', 'description': 'Total procedure duration (minutes) Duration of Pounce Thrombectomy System use (minutes)'}, {'measure': 'Characterize subject index procedure hospitalization course at discharge', 'timeFrame': 'Index procedure hospital admission to discharge, approximately 1 to 2 days', 'description': 'Length of stay'}, {'measure': 'Characterize subject index procedure hospitalization course at discharge', 'timeFrame': 'Index procedure hospital admission to discharge, approximately 1 to 2 days', 'description': 'Time from end of procedure to discharge'}, {'measure': 'Characterize subject index procedure hospitalization course at discharge', 'timeFrame': 'Index procedure hospital admission to discharge, approximately 1 to 2 days', 'description': 'Incidence of same day discharge'}, {'measure': 'Characterize subject index procedure hospitalization course at discharge', 'timeFrame': 'Index procedure hospital admission to discharge, approximately 1 to 2 days', 'description': 'Incidence of next day discharge'}, {'measure': 'Characterize subject index procedure hospitalization course at discharge', 'timeFrame': 'Index procedure hospital admission to discharge, approximately 1 to 2 days', 'description': 'Incidence of ICU admission'}, {'measure': 'Characterize subject index procedure hospitalization course at discharge', 'timeFrame': 'Index procedure hospital admission to discharge, approximately 1 to 2 days', 'description': 'Duration of ICU admission'}, {'measure': 'Primary vessel patency', 'timeFrame': '30 days', 'description': 'Determined by the investigator using DUS or ABI'}, {'measure': 'Rutherford class (if applicable)', 'timeFrame': 'Procedure to 30 days', 'description': 'Improvement by at least one class at 30 days as compared to procedure'}, {'measure': 'Rutherford classification (if applicable)', 'timeFrame': 'Baseline, at hospital discharge (approximately 1-2 days), 30 days', 'description': 'Characterize Rutherford classification'}, {'measure': 'Ankle Brachial Index (ABI)', 'timeFrame': 'Baseline to 30 days', 'description': 'Change in ABI at 30 days compared to baseline.'}, {'measure': 'Incidence of device related arterial AEs', 'timeFrame': '30 days', 'description': 'Major bleeding (requiring transfusion) Arterial perforation Flow-limiting dissection (at the end of the procedure, prior to and following stenting, if performed) Distal embolization requiring surgical procedure or obstructing one of the major downstream vessels \\>70% (at the end of the procedure)'}, {'measure': 'Incidence of all-cause: Death Unplanned major amputation (above ankle) Clinically driven TLR Clinically driven TVR', 'timeFrame': '30 days'}, {'measure': 'Incidence of: Procedure-related SAEs Device-related (S)AEs', 'timeFrame': '30 days'}, {'measure': 'Incidence of: Compartment syndrome requiring fasciotomy Major bleeding (requiring transfusion) unrelated to device', 'timeFrame': '30 days'}, {'measure': 'Incidence of index procedure access site complications', 'timeFrame': '30 days', 'description': 'Infection (requiring IV antibiotics or surgical treatment) Pseudoaneurysm (requiring surgical or endovascular treatment) Seroma (requiring surgical treatment) Other access site related AEs\n\n* Numbness\n* Other'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease', 'Acute Limb Ischemia']}, 'descriptionModule': {'briefSummary': 'The PROWL registry is an open-label retrospective, multi-center, US study of the Surmodics™ Pounce™ Thrombectomy System for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult subjects who have had an endovascular intervention where use of the Pounce Thrombectomy System was attempted', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject underwent an endovascular intervention where the Pounce Thrombectomy System was attempted\n* Subject is willing and able to provide informed consent prior to the collection of study data or a consent waiver is in place\n\nExclusion Criteria:\n\n* Subject is under the age of 18 years'}, 'identificationModule': {'nctId': 'NCT05868161', 'acronym': 'PROWL', 'briefTitle': 'Pounce™ Thrombectomy System Retrospective Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'SurModics, Inc.'}, 'officialTitle': 'Pounce™ Thrombectomy System Retrospective Registry', 'orgStudyIdInfo': {'id': 'SUR22-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective', 'description': 'All subjects in whom the Pounce Thrombectomy System was attempted will be included.', 'interventionNames': ['Device: Pounce Thrombectomy System']}], 'interventions': [{'name': 'Pounce Thrombectomy System', 'type': 'DEVICE', 'otherNames': ['Mechanical thrombectomy'], 'description': 'Non-surgical removal of thrombi and emboli from the peripheral arterial vasculature with the Pounce Thrombectomy System.', 'armGroupLabels': ['Retrospective']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61637', 'city': 'Peoria', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'OSF St. Francis Medical Center', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '46321', 'city': 'Munster', 'state': 'Indiana', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Community Hospital', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Baton Rouge General Medical Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Allina Health', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '29601', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Prisma Health Upstate', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '57108', 'city': 'Sioux Falls', 'state': 'South Dakota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'North Central Heart', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78723', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ascension Seton', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'centralContacts': [{'name': 'Clinical Program Manager', 'role': 'CONTACT', 'email': 'PROWLRegistry@surmodics.com', 'phone': '1-866-787-6639'}], 'overallOfficials': [{'name': 'Sean Lyden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Joseph Campbell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OhioHealth'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SurModics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}