Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-30 @ 9:41 AM
Study NCT ID:
NCT06929832
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-16
First Post:
2025-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration During Lower Extremity Tibial Interventions
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-04-08', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoint', 'timeFrame': '30 Days', 'description': 'The incidence, type, and severity of Protexus related major adverse events (MAEs) through 30-days defined as:\n\n* Death or organ injury\n* Thrombosis, pseudo-aneurysm, dissection (grade C or greater by visual assessment) or clinical perforation at the Protexus device location\n* Angiographically evident flow limiting distal embolization'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration during Lower Extremity Tibial Interventions', 'detailedDescription': 'This is a prospective, multi-center, non-randomized, open label, single arm post-market clinical study to gather data on the use of the Protexus catheter for temporary blood vessel occlusion while standard of care treatment with other therapeutic devices is conducted in patients undergoing infrapopliteal treatment for peripheral arterial disease (PAD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects being treated for PAD with standard of care interventions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is at least 18 years of age\n2. Subject or authorized representative has signed a written Informed Consent\n3. Subject is willing to comply with the protocol requirements\n4. Rutherford classification 4-6\n5. Planned intervention of the native infrapopliteal arteries using balloon angioplasty, atherectomy, and endovascular procedures.\n6. Reference vessel diameter for intended location of the distal tip funnel deployment for the Protexus catheter is ≥3.5mm and ≤6.0mm by visual estimate\n7. Inflow arteries have ≤30% stenosis. Inflow arteries can be treated at the time of the study procedure to achieve ≤30% stenosis\n\nExclusion Criteria:\n\n1. Prior intervention within 30 days of treatment in the planned deployment site for the Protexus catheter\n2. Presence of a stent in the planned deployment site for the Protexus catheter\n3. Has perforation, dissection, or other injury of the access vessel or Protexus catheter deployment site requiring additional stenting or surgical intervention before enrollment\n4. History of bleeding diathesis or coagulopathy and unable to receive standard anticoagulation during the index procedure\n5. Acute limb ischemia defined as onset of symptoms within two weeks of the planned intervention\n6. Inflow arteries have \\>30% stenosis after treatment at the time of the study procedure\n7. Pregnant female subject or subject that has a positive pregnancy test within the previous 7 days\n8. Known hypersensitivity or allergy to nitinol\n9. Target blood vessels are infected, have extreme tortuosity, or are occluded with calcified material'}, 'identificationModule': {'nctId': 'NCT06929832', 'acronym': 'Protexus 1', 'briefTitle': 'Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration During Lower Extremity Tibial Interventions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Protexa Endovascular, Inc.'}, 'officialTitle': 'Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration During Lower Extremity Tibial Interventions', 'orgStudyIdInfo': {'id': 'PR-100'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ryan Balko', 'role': 'CONTACT', 'email': 'ryan@vdcmedtech.com', 'phone': '612-251-2526'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Protexa Endovascular, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}