Service de Chirurgie Vasculaire, Hôpital Ambroise Paré
Boulogne-Billancourt, 92100, France
NCT Number: NCT04062734
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.
Looking for future studies?
Notify Me40 year–90 year
All sexes
Observational
Boulogne-Billancourt, 92100, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at 1 month
Evaluate primary patency at 1 month after in situ fenestration by CT angiography.
Time frame: at 1 month
Evaluate primary patency at 1 month after in situ fenestration by doppler ultrasound.
Time frame: at 6 and 12 month
Evaluate secondary patency at 6 and 12 month after in situ fenestration by CT angiography.
Time frame: at 6 and 12 month
Evaluate secondary patency at 6 and 12 month after in situ fenestration by doppler ultrasound.
Time frame: at baseline
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.
Assistance Publique - Hôpitaux de Paris
Other
Acronym: PREFISIT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02689414
Abdominal Aortic Aneurysm, Aneurysm
Tartu, Tartu County, Estonia
View Trial DetailsNCT01897103
Amputation, Wound, Aneurysm
New York, United States
View Trial DetailsNCT04377126
Arterial Occlusive Diseases, Arteriosclerosis
Chicago, Illinois, United States
View Trial DetailsNCT06890208
Anxiety Disorders, Arrhythmias, Cardiac
Hamburg, Germany
View Trial Details