Clinical trial NCT03613883: The Endovascular Management of Visceral Artery Aneurysms
Official title: The Endovascular Management of Visceral Artery Aneurysms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Visceral Artery Aneurysm
Keywords: aneurysm
embolization
stent graft
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To describe the safety, possible complications and technical success of different technical methods and different embolic materials in the endovascular management of visceral artery aneurysms.

Detailed description: Abdominal visceral artery aneurysms (VAAs) are defined as aneurysms which involve branches of the celiac, superior mesenteric, inferior mesenteric or renal arteries. Owing to the improvements in imaging technology and the use of cross-sectional imaging modalities (ultrasound, computed tomography \[CT\], and magnetic resonance imaging), there is increase in the frequency of VAAs diagnosis. Although classically treated by open surgery, modern treatment strategies generally place interventional radiology techniques at the top of the treatment algorithm. Therefore, vascular interventional radiologists must become familiar with the indications for the treatment of VAA, become experienced in the different techniques, and know when to recommend treatment of VAA by interventional radiology techniques or to advocate open surgical repair.

VAAs are subdivided into true and false aneurysms. A true aneurysm involves all three layers of the arterial wall. Classically, a true aneurysm is defined as a localized dilatation of the artery by more than 1.5 times the expected arterial diameter. True aneurysms occur as a result of underlying arterial pathology such as atherosclerosis, fibromuscular dysplasia, and arteritis. The prevalence of true VAAs is 0.1-2%, and most true VAAs are asymptomatic. A minority may cause abdominal pain, which may be a harbinger of imminent rupture. VAAs are almost never large enough to be palpable by examination. False aneurysms, or pseudoaneurysms, are effectively contained ruptures of the artery that are lined by adventitia or by the perivascular tissues. False aneurysms may occur as a result of inflammation, infection, or trauma.

Eligibility criteria: Inclusion Criteria:

* Aneurysm due to inflammation or pancreatitis \[e.g., splenic, gastroduodenal (GDA), superiomesenteric artery (SMA), hepatic, or even renal aneurysms\].
* Aneurysm due to trauma.
* Aneurysms occurring after surgery
* Aneurysm due to penetrating peptic ulcers.

Exclusion Criteria:

* In most cases with multiple, diffuse, small aneurysms related to portal hypertension should be left untreated and followed by repeat computed tomography (CT) or magnetic resonance imaging (MRI) examinations. Once the portal hypertension and underlying cirrhotic disease is treated (e.g., via liver transplantation), the aneurysm may spontaneously decrease and completely disappear over time.
* Patient refusal.

Primary outcomes:
measure: Complete aneurysm exclusion at the final angiographic control with absence of contrast extravasation and cessation of haemorrhage.
timeFrame: At immediate post-procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Radiology Department in Assiut University Hospital
name: Mostafa H Othman, M.D.
role: STUDY_DIRECTOR
References: