PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

Официальное название

Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts

Обзор

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.

Вмешательства

• Устройство PMEG
  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.

Первичные конечные точки

• Number of subjects with 30-day major adverse events from primary procedure [Срок оценки: Day 30]
• Number of subjects with treatment success [Срок оценки: Month 12]

Вторичные конечные точки (2)

• Number of subjects with mortality, major adverse events, spinal cord ischemia [Срок оценки: Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60]
• Number of subjects with treatment success and freedom from secondary intervention [Срок оценки: Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60]

Критерии участия

Критерии включения

• Provision of signed and dated informed consent form
• Male or female, aged ≥18 years
• Expected survival beyond 1 year following successful aneurysm repair
• 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
• Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection
• Adequate proximal zone of fixation
• Adequate distal zone of fixation
• No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm
• Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary

Критерии исключения

• Moderate-to-severe aortic neck calcification, thrombus, or tortuosity
• Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit
• Proximal landing within zone 0 or 1
• Inability to maintain at least one patent hypogastric artery
• Freely ruptured aneurysm with hemodynamic instability
• Non-ambulatory status
• Severe CHF
• Baseline eGFR < 30ml/min, unless currently on or to be initiating dialysis
• Unstable angina
• Stroke or MI within 3 months of planned treatment date
• Active systemic infection and/or mycotic aneurysm
• Uncorrectable coagulopathy or other bleeding diathesis
• Known allergy to device material or contrast material that cannot be adequately pre-medicated
• Body habitus that would preclude adequate fluoroscopic visualization of aorta
• Pregnancy or lactation (confirmed per standard of care surgical practice)
• Major, unrelated surgical procedure planned ≤30 days from endovascular repair
• Patient is ≤30 days beyond primary endpoint for another investigative clinical drug/device trial
• Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study
• Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Tampa General Hospital — Tampa
• University of South Florida - South Tampa Campus — Tampa

Публикации

• 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 29224942
• 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 30583902
• 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 26792544
• 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 28259577
• 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 27986479
• 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 17257941
• 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 17257942
• 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 19362499

Идентификаторы

NCT: NCT05195905 · STUDY002613

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗