Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-01-09 @ 4:40 PM
Study NCT ID:
NCT05195905
Status:
RECRUITING
Last Update Posted:
2025-04-16
First Post:
2022-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094624', 'term': 'Aortic Aneurysm, Thoracoabdominal'}], 'ancestors': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2022-01-04', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with 30-day major adverse events from primary procedure', 'timeFrame': 'Day 30', 'description': 'Major adverse events include: aortic-related mortality, major stroke, myocardial Infarction, permanent spinal cord ischemia, renal failure, bowel Ischemia (requiring laparotomy/bowel resection), respiratory failure (mechanical ventilation \\>72 hours or requiring tracheostomy), lower extremity ischemia, blood loss ≥1,000cc'}, {'measure': 'Number of subjects with treatment success', 'timeFrame': 'Month 12', 'description': 'Treatment success is defined as a composite of: technical success, device integrity (freedom from stent fractures), freedom from aortic enlargement ≥5mm compared to preoperative CT imaging, freedom from aortic rupture, freedom from reintervention for type I or III endoleak or patency-related event, freedom from conversion to open aneurysm repair, freedom from aneurysm-related mortality.'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with mortality, major adverse events, spinal cord ischemia', 'timeFrame': 'Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60', 'description': 'Mortality includes all-cause mortality. Major adverse events include: aortic-related mortality, major stroke, myocardial Infarction, permanent spinal cord ischemia, renal failure, bowel Ischemia (requiring laparotomy/bowel resection), respiratory failure (mechanical ventilation \\>72 hours or requiring tracheostomy), lower extremity ischemia, blood loss ≥1,000cc. Spinal cord ischemia data will include all incidence and degree of spinal cord ischemia.'}, {'measure': 'Number of subjects with treatment success and freedom from secondary intervention', 'timeFrame': 'Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60', 'description': 'Treatment success is defined as a composite of: technical success, device integrity (freedom from stent fractures), freedom from aortic enlargement ≥5mm compared to preoperative CT imaging, freedom from aortic rupture, freedom from reintervention for type I or III endoleak or patency-related event, freedom from conversion to open aneurysm repair, freedom from aneurysm-related mortality. Freedom from secondary interventions includes interventions to treat malperfusion, rupture, aneurysm formation, aortic expansion, endoleak, device stenosis/occlusion, or access site complication.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pararenal Aortic Aneurysm', 'Thoracoabdominal Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '29224942', 'type': 'BACKGROUND', 'citation': 'Dossabhoy SS, Simons JP, Flahive JM, Aiello FA, Sheth P, Arous EJ, Messina LM, Schanzer A. Fenestrated endovascular aortic aneurysm repair using physician-modified endovascular grafts versus company-manufactured devices. J Vasc Surg. 2018 Jun;67(6):1673-1683. doi: 10.1016/j.jvs.2017.10.055. Epub 2017 Dec 8.'}, {'pmid': '30583902', 'type': 'BACKGROUND', 'citation': 'Oderich GS, Ribeiro MS, Sandri GA, Tenorio ER, Hofer JM, Mendes BC, Chini J, Cha S. Evolution from physician-modified to company-manufactured fenestrated-branched endografts to treat pararenal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2019 Jul;70(1):31-42.e7. doi: 10.1016/j.jvs.2018.09.063. Epub 2018 Dec 21.'}, {'pmid': '26792544', 'type': 'BACKGROUND', 'citation': 'Eagleton MJ, Follansbee M, Wolski K, Mastracci T, Kuramochi Y. Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms. J Vasc Surg. 2016 Apr;63(4):930-42. doi: 10.1016/j.jvs.2015.10.095. Epub 2016 Jan 11.'}, {'pmid': '28259577', 'type': 'BACKGROUND', 'citation': 'Schanzer A, Simons JP, Flahive J, Durgin J, Aiello FA, Doucet D, Steppacher R, Messina LM. Outcomes of fenestrated and branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2017 Sep;66(3):687-694. doi: 10.1016/j.jvs.2016.12.111. Epub 2017 Mar 1.'}, {'pmid': '27986479', 'type': 'BACKGROUND', 'citation': 'Oderich GS, Ribeiro M, Hofer J, Wigham J, Cha S, Chini J, Macedo TA, Gloviczki P. Prospective, nonrandomized study to evaluate endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts based on supraceliac sealing zones. J Vasc Surg. 2017 May;65(5):1249-1259.e10. doi: 10.1016/j.jvs.2016.09.038. Epub 2016 Dec 13.'}, {'pmid': '17257941', 'type': 'BACKGROUND', 'citation': 'Conrad MF, Crawford RS, Davison JK, Cambria RP. Thoracoabdominal aneurysm repair: a 20-year perspective. Ann Thorac Surg. 2007 Feb;83(2):S856-61; discussion S890-2. doi: 10.1016/j.athoracsur.2006.10.096.'}, {'pmid': '17257942', 'type': 'BACKGROUND', 'citation': 'Coselli JS, Bozinovski J, LeMaire SA. Open surgical repair of 2286 thoracoabdominal aortic aneurysms. Ann Thorac Surg. 2007 Feb;83(2):S862-4; discussion S890-2. doi: 10.1016/j.athoracsur.2006.10.088.'}, {'pmid': '19362499', 'type': 'BACKGROUND', 'citation': 'Schepens MA, Heijmen RH, Ranschaert W, Sonker U, Morshuis WJ. Thoracoabdominal aortic aneurysm repair: results of conventional open surgery. Eur J Vasc Endovasc Surg. 2009 Jun;37(6):640-5. doi: 10.1016/j.ejvs.2009.03.011. Epub 2009 Apr 11.'}, {'pmid': '31727462', 'type': 'BACKGROUND', 'citation': 'Arnaoutakis DJ, Scali ST, Beck AW, Kubilis P, Huber TS, Martin AJ, Laquian L, Back M, Giles KA, Fatima J, Beaver TM, Upchurch GR Jr. Comparative outcomes of open, hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms. J Vasc Surg. 2020 May;71(5):1503-1514. doi: 10.1016/j.jvs.2019.08.236. Epub 2019 Nov 11.'}, {'pmid': '29017806', 'type': 'BACKGROUND', 'citation': 'Scali ST, Kim M, Kubilis P, Feezor RJ, Giles KA, Miller B, Fatima J, Huber TS, Berceli SA, Back M, Beck AW. Implementation of a bundled protocol significantly reduces risk of spinal cord ischemia after branched or fenestrated endovascular aortic repair. J Vasc Surg. 2018 Feb;67(2):409-423.e4. doi: 10.1016/j.jvs.2017.05.136. Epub 2017 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Male or female, aged ≥18 years\n3. Expected survival beyond 1 year following successful aneurysm repair\n4. Anatomy that would require coverage of the celiac artery, superior mesenteric artery (SMA), and/or renal arteries if conventional, FDA-approved endograft were implanted to obtain adequate sealing zone length\n5. Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection\n6. Adequate proximal zone of fixation\n7. Adequate distal zone of fixation\n8. No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm\n9. Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary\n\nExclusion Criteria:\n\n1. Moderate-to-severe aortic neck calcification, thrombus, or tortuosity\n2. Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit\n3. Proximal landing within zone 0 or 1\n4. Inability to maintain at least one patent hypogastric artery\n5. Freely ruptured aneurysm with hemodynamic instability\n6. Non-ambulatory status\n7. Severe CHF\n8. Baseline eGFR \\< 30ml/min, unless currently on or to be initiating dialysis\n9. Unstable angina\n10. Stroke or MI within 3 months of planned treatment date\n11. Active systemic infection and/or mycotic aneurysm\n12. Uncorrectable coagulopathy or other bleeding diathesis\n13. Known allergy to device material or contrast material that cannot be adequately pre-medicated\n14. Body habitus that would preclude adequate fluoroscopic visualization of aorta\n15. Pregnancy or lactation (confirmed per standard of care surgical practice)\n16. Major, unrelated surgical procedure planned ≤30 days from endovascular repair\n17. Patient is ≤30 days beyond primary endpoint for another investigative clinical drug/device trial\n18. Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study\n19. Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device\n20. Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution'}, 'identificationModule': {'nctId': 'NCT05195905', 'briefTitle': 'PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts', 'orgStudyIdInfo': {'id': 'STUDY002613'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physician-modified endografts', 'description': 'For this clinical protocol, endografts which are commercially available will be modified in a sterile fashion on a back-table in the operating room.', 'interventionNames': ['Device: PMEG']}], 'interventions': [{'name': 'PMEG', 'type': 'DEVICE', 'description': 'All devices that will be modified in this study protocol are commercially available in the United States. The commercially available endografts will be used to construct a fenestrated/branched device for this intervention.', 'armGroupLabels': ['Physician-modified endografts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Beth Montera', 'role': 'CONTACT', 'email': 'bmontera@usf.edu', 'phone': '813-844-7948'}, {'name': 'Cara Grzybowski', 'role': 'CONTACT', 'email': 'cgrzybowski@usf.edu', 'phone': '813-844-7948'}, {'name': 'Konstantinos Arnaoutakis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Beth Montera', 'role': 'CONTACT', 'email': 'bmontera@usf.edu', 'phone': '813-844-7948'}, {'name': 'Cara Grzybowski, BS', 'role': 'CONTACT', 'email': 'cgrzybowski@usf.edu', 'phone': '8138447873'}, {'name': 'Konstantinos Arnaoutakis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of South Florida - South Tampa Campus', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Beth Montera', 'role': 'CONTACT', 'email': 'bmontera@usf.edu', 'phone': '8138447948'}, {'name': 'Konstantinos Arnaoutakis, MD', 'role': 'CONTACT', 'email': 'arnaoutakis@usf.edu'}], 'overallOfficials': [{'name': 'Konstantinos Arnaoutakis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konstantinos Dean Arnaoutakis, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Konstantinos Dean Arnaoutakis, MD', 'investigatorAffiliation': 'University of South Florida'}}}}