The Endovascular Management of Visceral Artery Aneurysms

NCT ID: NCT03613883

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2021-12-31

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.

Conditions

Visceral Artery Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Primary Study Arm

The intervention is done to those patients that are managed by endovascular stent that is inserted in the parent artery to induce slowness in the blood flow thus initiate thrombosis in the aneurysmal sac.

Group Type: EXPERIMENTAL

Endovascular management

Intervention Type: PROCEDURE

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

Expanded Selection Arm

The intervention is done to the expanded selection arm and is managed by embolic materials (coils / glue) that occlude the aneurysm by proximal occlusion, proximal and distal occlusion or sac packing

Group Type: EXPERIMENTAL

Endovascular management

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud K. khairallah

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mostafa H Othman, M.D.

Role: STUDY_DIRECTOR

Radiology Department in Assiut University Hospital

Central Contacts

Mahmoud K khairallah, master

Role: CONTACT

m.khairallah@aun.edu.eg

+201149855332

Other Identifiers

endovascular in aneurysms

Identifier Type: -

Identifier Source: org_study_id