Clinical trial NCT04062734: Endovascular Treatment of Aorto-iliac Disease Using in Situ Fenestration
Official title: Endovascular Treatment of Aorto-iliac Disease Using in Situ Fenestration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Abdominal Aortic Aneurysm
Keywords: Peripheral artery disease
abdominal aortic aneurysm
in situ fenestration
endovascular treatment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients have been operated with in situ fenestration between 2014 and 2019.

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

- Underwent in situ fenestration treatment between 2014 and 2019

Exclusion Criteria:

* Patient aged \< 40 years or \> 90 years
* Under guardianship

Primary outcomes:
measure: Primary Patency
timeFrame: at 1 month
measure: Primary Patency
timeFrame: at 1 month
Secondary outcomes:
measure: Secondary Patency
timeFrame: at 6 and 12 month
measure: Secondary Patency
timeFrame: at 6 and 12 month
measure: Technical success
timeFrame: at baseline
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Service de Chirurgie Vasculaire, Hôpital Ambroise Paré
Study officials:
affiliation: Service de Chirurgie Vasculaire, Hôpital Ambroise Paré
name: Raphaël COSCAS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Chirurgie Vasculaire, Hôpital Ambroise Paré
name: Jérémie JAYET, MD
role: STUDY_DIRECTOR
References: