NCT05195905

PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Konstantinos Dean Arnaoutakis, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pararenal Aortic Aneurysm
• Thoracoabdominal Aortic Aneurysm

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-06
• Primary completion: 2029-02-01
• Completion: 2029-08-01
• First posted: 2022-01-19
• Last updated: 2025-04-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study