Ignite Creation Date:
2024-05-06 @ 1:35 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04062734
Status:
COMPLETED
Last Update Posted:
2020-12-07
First Post:
2019-07-01
Brief Title:
Endovascular Treatment of Aorto-iliac Disease Using in Situ Fenestration
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Endovascular Treatment of Aorto-iliac Disease Using in Situ Fenestration
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREFISIT
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 agentaspirin75-250mddl or clopidogrel 75mddl 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
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 agentaspirin75-250mddl or clopidogrel 75mddl 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None