Standardized Physician-modified Fenestrated Endograft Registry

NCT06358248 | Recruiting FDA Device

• 1 other identifier: SPHERE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Aortic Aneurysm; Thoracoabdominal Aneurysm; Endovascular aortic repair

Outcome Measures

Primary Outcomes (3)

• Technical success

  Number of participants who underwent a successful deployment of the endograft and stenting of the 4 visceral vessels

  Intra-operative

• Freedom from target vessel instability

  Number of participants who experience any occlusion, endoleak, aneurysm rupture, stent restenosis needing a re-intervention

  5 years

• Freedom from endograft instability

  Number of participants who show absence of endoleak, aneurysm rupture, endograft migration

  5 years

Secondary Outcomes (2)

• Early (30-days) Major Adverse Event (MAE)

  5 years

• Aneurysm sac dynamics

  5 years

Study Arms (1)

Patients treated

All patients treated with 4-fen PMEG endograft

Device: Physician-modification of Valiant Captivia Endograft (Medtronic, Minneapolis, MN-USA).

Interventions

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

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.

Patients treated

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent e PMEG with 4-fenestration procedure for the treatment of a short neck AAA, juxta/para-renal AAA, and type IV thoracoabdominal aneurysm (TAAA).

You may qualify if:

• Complex AAA (including short-neck AAA, JRAA, PRAA, extent IV TAAA)
• Haemodynamic stability
• Anatomical feasibility is based on the presence of a proximal aortic neck above the mid celiac trunk of ≥25 mm in length and between 18 mm and 35 mm in diameter; the neck needs to be "healthy" with no parietal calcifications or thrombus with a cylindrical shape. The visceral aorta is required to be no larger than 40 mm in maximum diameter.

You may not qualify if:

• Extent I-III TAAA
• Hemorrhagic shock

Sponsors & Collaborators

• University Hospital Padova: lead

Study Sites (1)

Vascular and Endovascular Clinic - Padova University

Padua, 35020, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal; Aortic Diseases; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michele Piazza, MD

  University Hospital Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Piazza, MD

CONTACT

0498218154; michele.piazza@unipd.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 10, 2024
• Study Start: October 1, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2033
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

IT (1)