Thoracoabdominal Aortic Aneurysm Clinical Trial
Official title:
Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts
NCT number | NCT05195905 |
Other study ID # | STUDY002613 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 6, 2023 |
Est. completion date | August 2029 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | August 2029 |
Est. primary completion date | February 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Male or female, aged =18 years 3. Expected survival beyond 1 year following successful aneurysm repair 4. 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 5. Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection 6. Adequate proximal zone of fixation 7. Adequate distal zone of fixation 8. No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm 9. Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary Exclusion Criteria: 1. Moderate-to-severe aortic neck calcification, thrombus, or tortuosity 2. Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit 3. Proximal landing within zone 0 or 1 4. Inability to maintain at least one patent hypogastric artery 5. Freely ruptured aneurysm with hemodynamic instability 6. Non-ambulatory status 7. Severe CHF 8. Baseline eGFR < 30ml/min, unless currently on or to be initiating dialysis 9. Unstable angina 10. Stroke or MI within 3 months of planned treatment date 11. Active systemic infection and/or mycotic aneurysm 12. Uncorrectable coagulopathy or other bleeding diathesis 13. Known allergy to device material or contrast material that cannot be adequately pre-medicated 14. Body habitus that would preclude adequate fluoroscopic visualization of aorta 15. Pregnancy or lactation (confirmed per standard of care surgical practice) 16. Major, unrelated surgical procedure planned =30 days from endovascular repair 17. Patient is =30 days beyond primary endpoint for another investigative clinical drug/device trial 18. Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study 19. Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device 20. 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 |
Country | Name | City | State |
---|---|---|---|
United States | Tampa General Hospital | Tampa | Florida |
United States | University of South Florida - South Tampa Campus | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Konstantinos Dean Arnaoutakis, MD |
United States,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subjects with 30-day major adverse events from primary procedure | 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 | Day 30 | |
Primary | Number of subjects with treatment success | 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. | Month 12 | |
Secondary | Number of subjects with mortality, major adverse events, spinal cord ischemia | 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. | Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 | |
Secondary | Number of subjects with treatment success and freedom from secondary intervention | 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. | Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 |
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