RecruitingNCT06358248

Standardized Physician-modified Fenestrated Endograft Registry

Sponsor

University Hospital Padova

Enrollment

50 participants

Start Date

Oct 1, 2023

Study Type

OBSERVATIONAL

Conditions

Aortic Diseases Aortic Aneurysm, Thoracoabdominal

Summary

Multicenter retrospective study including all consecutive patients treated by PMEG using a standard modification technique of Valiant Captivia (Medtronic, Minneapolis, MN-USA).

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Physician-modification of Valiant Captivia Endograft (Medtronic, Minneapolis, MN-USA). for people with aortic aneurysm, thoracoabdominal and aortic diseases. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 100 Years.

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

DEVICEPhysician-modification of Valiant Captivia Endograft (Medtronic, Minneapolis, MN-USA).

On a sterile back-table a Valiant Captivia thoracic graft is deployed. A dotted line is drawn to mark the graft anterior 0° degree, and fabric holes are performed with cautery in the desired position. The fenestrations need to be 6x6 mm for the renals and 8x8 mm for superior mesenteric artery (SMA) and celiac trunk (CT), and are reinforced with the tip of a 0.018 guidewire through a continuous 5-0 locking suture. A posterior constraining wire is created to reduce the diameter of the graft by 20-30%, in order to allow rotation during the deployment phase. The four "8" markers on the top of the graft are carefully removed with a scalpel; one of these is modified as an "S" and re-sutured on the anterior aspect at 0 degree position, with a 5-0 prolene continuous suture. This "S" marker will allow anteroposterior graft orientation. Finally, the graft is re-sheathed and deployed.