PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05195905
• Other study ID #: STUDY002613
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2023
• Est. completion date: August 2029

Study information

• Verified date: July 2023
• Source: University of South Florida
• Contact: Beth Montera
• Phone: 8138447948
• Email: bmontera[@]usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Aneurysm, Thoracoabdominal
• Pararenal Aortic Aneurysm
• Thoracoabdominal Aortic Aneurysm

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida
United States	University of South Florida - South Tampa Campus	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Konstantinos Dean Arnaoutakis, MD

Country where clinical trial is conducted

United States, 

References & Publications (10)

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

Outcome

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