Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06358248

Standardized Physician-modified Fenestrated Endograft Registry

Sponsor: University Hospital Padova

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2023-10-01

Completion Date

2033-10-01

Last Updated

2024-04-16

Healthy Volunteers

No

Interventions

DEVICE

Physician-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.

Locations (1)

Vascular and Endovascular Clinic - Padova University

Padova, Italy