The Endovascular Management of Visceral Artery Aneurysms

NCT03613883 | Unknown

• 1 other identifier: endovascular in aneurysms
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Visceral Artery Aneurysm

Keywords

aneurysm; embolization; stent graft

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Primary Study Arm

EXPERIMENTAL

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.

Procedure: Endovascular management

Expanded Selection Arm

EXPERIMENTAL

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

Procedure: Endovascular management

Interventions

Endovascular management 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; Primary Study Arm

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mostafa H Othman, M.D.

  Radiology Department in Assiut University Hospital

  STUDY DIRECTOR

Central Study Contacts

Mahmoud K khairallah, master

CONTACT

+201149855332; m.khairallah@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: August 3, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2021
• Last Updated: August 3, 2018

Record last verified: 2018-08