Endovascular Treatment of Aorto-iliac Disease Using in Situ Fenestration (PREFISIT)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease; Abdominal Aortic Aneurysm

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Boulogne-Billancourt, France, 92100
    • Service de Chirurgie Vasculaire, Hôpital Ambroise Paré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

- Underwent in situ fenestration treatment between 2014 and 2019

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency	Evaluate primary patency at 1 month after in situ fenestration by CT angiography.	at 1 month
Primary Patency	Evaluate primary patency at 1 month after in situ fenestration by doppler ultrasound.	at 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Patency	Evaluate secondary patency at 6 and 12 month after in situ fenestration by CT angiography.	at 6 and 12 month
Secondary Patency	Evaluate secondary patency at 6 and 12 month after in situ fenestration by doppler ultrasound.	at 6 and 12 month
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.	at baseline

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Raphaël COSCAS, MD, PhD, Service de Chirurgie Vasculaire, Hôpital Ambroise Paré; Study Director: Jérémie JAYET, MD, Service de Chirurgie Vasculaire, Hôpital Ambroise Paré

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 27, 2020
• Primary Completion (ACTUAL): December 2, 2020
• Study Completion (ACTUAL): December 2, 2020

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (ACTUAL): August 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: endovascular treatment; Peripheral artery disease; abdominal aortic aneurysm; in situ fenestration
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Aortic Diseases; Peripheral Arterial Disease; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 19RCS-PREFISIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No