Endovascular Treatment of Aorto-iliac Disease Using in Situ Fenestration

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Endovascular Treatment of Aorto-iliac Disease Using in Situ Fenestration

Official Title

Endovascular Treatment of Aorto-iliac Disease Using in Situ Fenestration

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.

Study Type

Observational

Primary Outcome

Primary Patency

Secondary Outcome

 Secondary Patency

Condition

Peripheral Artery Disease

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

30

Start Date

November 27, 2020

Completion Date

December 2, 2020

Primary Completion Date

December 2, 2020

Eligibility Criteria

        Inclusion Criteria:

        - Underwent in situ fenestration treatment between 2014 and 2019

        Exclusion Criteria:

          -  Patient aged < 40 years or > 90 years

          -  Under guardianship

Gender

All

Ages

40 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Raphaël COSCAS, MD, PhD, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT04062734

Organization ID

19RCS-PREFISIT

Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris

Study Sponsor

Raphaël COSCAS, MD, PhD, Principal Investigator, Service de Chirurgie Vasculaire, Hôpital Ambroise Paré

Verification Date

December 2020