RecruitingNot ApplicableNCT05195905

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

Sponsor

Konstantinos Dean Arnaoutakis, MD

Enrollment

30 participants

Start Date

Jun 6, 2023

Study Type

INTERVENTIONAL

Conditions

Pararenal Aortic Aneurysm Thoracoabdominal Aortic Aneurysm

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a physician-modified endovascular graft (PMEG)—a customized stent-graft—for repairing complex aortic aneurysms that involve the major vessels supplying blood to the kidneys and intestines (pararenal or thoracoabdominal aneurysms). These are difficult to treat with standard off-the-shelf devices. You may be eligible if: - You are 18 or older - You have a pararenal or thoracoabdominal aortic aneurysm that cannot be treated with a standard endovascular device - You have a life expectancy greater than 1 year after successful repair - Your anatomy meets specific criteria for the graft to seal properly You may NOT be eligible if: - You have a ruptured aneurysm with unstable blood pressure - You have severe kidney disease (eGFR below 30 mL/min) unless on dialysis - You had a stroke or heart attack within the past 3 months - You are pregnant or breastfeeding - You have active infection or are unable to comply with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPMEG

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.