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Standardized Physician-modified Fenestrated Endograft Registry

ConditionsAortic Aneurysm, ThoracoabdominalAortic Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity Hospital Padova

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Extent I-III TAAA

Hemorrhagic shock

Trial 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).

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patients treated1 intervention

Trial outcomes

Primary outcomes

1

Technical success

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

Time frame
Intra-operative
2

Freedom from target vessel instability

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

Time frame
5 years
3

Freedom from endograft instability

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

Time frame
5 years

Secondary outcomes

1

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

Any early (30-days) Major Adverse Event

Time frame
5 years
2

Aneurysm sac dynamics

Number of participants who experience aneurysm sac diameter change during follow-up

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Padova

Lead sponsor

Source ClinicalTrials.gov
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