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Standardized Physician-modified Fenestrated Endograft Registry

NCT06358248 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-04-16

No results posted yet for this study

Summary

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

Conditions

  • Aortic Aneurysm, Thoracoabdominal
  • Aortic Diseases

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.

Sponsors & Collaborators

  • University Hospital Padova

    lead OTHER

Principal Investigators

  • Michele Piazza, MD · University Hospital Padova

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2028-10-01
Completion
2033-10-01
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06358248 on ClinicalTrials.gov