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Peripheral Artery DiseasePREFISITNCT04062734

Endovascular Treatment of Aorto-iliac Disease Using in Situ Fenestration

An observational study of Peripheral Artery Disease and Abdominal Aortic Aneurysm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In situ fenestration (ISF) could represent an alternative in the treatment of aorto-iliac disease when usual techniques are not available. The aim of this study was to present the results of ISF in aorto-iliac disease. Data will retrospectively be analyzed. Read more about this study

Who is it for?
Ages 40 to 90 years
How many people
30 participants
Where
1 siteFrance
Study dates
27 Nov 2020to 2 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients have been operated with in situ fenestration between 2014 and 2019.

Who may be able to join

  • Underwent in situ fenestration treatment between 2014 and 2019

Who cannot join

  • Patient aged < 40 years or > 90 years
  • Under guardianship

Trial locations and contacts

1 site in 1 country.

France1 site
  • Service de Chirurgie Vasculaire, Hôpital Ambroise Paré

    Boulogne-Billancourt, 92100

Other trials in France

About this study

In situ fenestration (ISF) could represent an alternative in the treatment of aorto-iliac disease when usual techniques are not available. The aim of this study was to present the results of ISF in aorto-iliac disease. Data will retrospectively be analyzed. Inclusion criteria will be: a surgical abdominal aortic aneurysm (AAA) with an unsuitable anatomy for a standard endograft, aorto-iliac occlusion with narrow distal aorta (<14mm). Technically, after placement of the endograft, a transjugular intrahepatic access set was used to perform ISF. The hole was secondary enlarged using a cutting or non-compliant balloon. Finally, a kissing stent was performed to the aorto- uni-iliac into a bifurcated endograft.

Read the detailed description

ISF are mainly described at the level of the aortic arch. Different means are reported to perforate the graft: the mechanical (needles, transjugular intra hepatic access needles or guidewires) or physical (laser and radiofrequency catheters).

ISF could be an alternative in the endovascular treatment of aorto iliac disease including both occlusive and aneurysmal pathologies. In this cases, when a narrow distal aorta is present conventional technique as CERAB, bifurcated endograft are challenging. In situ fenestrations allows conversion of an aorto-uni-iliac endograft into a bifurcated endograft, thereby avoiding crossover femorofemoral bypass and its complications.

The aim of the study was to report the results of ISF technique at the level of the abdominal aorta.

Inclusion criteria will be: a surgical abdominal aortic aneurysm (AAA) with an unsuitable anatomy for a standard endograft, aorto-iliac occlusion with narrow distal aorta (<14mm).

All patients had a preoperative CT scan to assess the anatomy of the abdominal aorta.

All patients received an oral antiplatelet agent(aspirin(75-250md/dl) or clopidogrel (75md/dl) and a statin before the procedure.

In situ fenestration technique The procedure was performed under general anesthesia and guided with a mobile C-arm (Siemens). The less diseased and tortuous iliac axis was used to introduce the endograft and the contralateral side as used for the in situ fenestration.

Whenever possible, the procedure was carried out percutaneously with the preclosure technique using Proglide vascular devices for the two common femoral artery retrograde punctures.

The first step consisted in placing an endograft from a retrograde femoral access. The endograft was deployed in a standard fashion. The distal security wire was not released to maintain the control on the distal part of the endograft and keep the graft straight while performing the fenestration. A transjugular intrahepatic access needle was introduced in a 9F Flexor introducer through a contralateral femoral access. When the top of the introducer was at the level of the aortic bifurcation, the dilatator of the introducer was removed, and the introducer was pushed up to the endograft. Contact between the introducer and the endograft was ensured by observing a slight deformation of the endograft while pushing the introducer.

The needle was advanced and the endograft is punctured at the level of the aortic bifurcation. The hole created was secondary enlarged using cutting or high pressure balloon. A long sheath is advanced intro the fenestration to control the success of the technique.

A kissing stent using balloon expandable covered stents is finally performed to stabilize the repair.

Control angiography confirm the patency of the stents and the absence of early endoleak in case of endovascular treatment of abdominal aortic aneurysm.

Keywords
Peripheral artery disease, abdominal aortic aneurysm, in situ fenestration, endovascular treatment
Medical subject headings
Peripheral Arterial Disease, Aortic Aneurysm, Abdominal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Patency

    Evaluate primary patency at 1 month after in situ fenestration by CT angiography.

    Measured: at 1 month

  2. Primary Patency

    Evaluate primary patency at 1 month after in situ fenestration by doppler ultrasound.

    Measured: at 1 month

Secondary outcomes (3)
  1. Secondary Patency

    Evaluate secondary patency at 6 and 12 month after in situ fenestration by CT angiography.

    Measured: at 6 and 12 month

  2. Secondary Patency

    Evaluate secondary patency at 6 and 12 month after in situ fenestration by doppler ultrasound.

    Measured: at 6 and 12 month

  3. Technical success

    Technical success was achieved when the perforation of the endograft was performed with the needle. Technical success will be measured as a ratio between the number of successfull perforation and the number of attempts.

    Measured: at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2019
  2. Study start27 Nov 2020
  3. Primary completion2 Dec 2020
  4. Study completion2 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04062734
Sponsor's protocol ID
APHP190689
Acronym
PREFISIT
Status last verified
Dec 2020
First submitted
1 Jul 2019
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Artery Disease and Abdominal Aortic Aneurysm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Patency (time frame: at 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.

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