The Endovascular Management of Visceral Artery Aneurysms

Visceral Artery Aneurysm Clinical Trial

Official title:

The Endovascular Management of Visceral Artery Aneurysms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03613883
• Other study ID #: endovascular in aneurysms
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2019
• Est. completion date: December 2021

Study information

• Verified date: August 2018
• Source: Assiut University
• Contact: Mahmoud K khairallah, master
• Phone: +201149855332
• Email: m.khairallah[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Visceral Artery Aneurysm

Intervention

Procedure:
• Endovascular management
Embolic materials (coils / glue): the glue will be routinely used when access into the aneurysm's outflow vessel will be unattainable. Endovascular stent to slow the flow inducing thrombosis of the sac of aneurysm. CT angiography will be performed later to evaluate and confirm the diagnosis and viability of the endovascular procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete aneurysm exclusion at the final angiographic control with absence of contrast extravasation and cessation of haemorrhage.	Complete aneurysm exclusion at the final angiographic control with absence of contrast extravasation and cessation of haemorrhage, if originally present. In instances of aneurysmal disease of second-order or third-order branches, technical success is further defined as exclusion of the aneurysm with preservation of flow within the intended parent artery.	At immediate post-procedure