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The Endovascular Management of Visceral Artery Aneurysms

Primary Purpose

Visceral Artery Aneurysm

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endovascular management
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visceral Artery Aneurysm focused on measuring aneurysm, embolization, stent graft

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Primary Study Arm

    Expanded Selection Arm

    Arm Description

    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.

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 29, 2018
    Last Updated
    August 2, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03613883
    Brief Title
    The Endovascular Management of Visceral Artery Aneurysms
    Official Title
    The Endovascular Management of Visceral Artery Aneurysms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2019 (Anticipated)
    Primary Completion Date
    January 2020 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Visceral Artery Aneurysm
    Keywords
    aneurysm, embolization, stent graft

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Primary Study Arm
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Expanded Selection Arm
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Endovascular management
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Complete aneurysm exclusion at the final angiographic control with absence of contrast extravasation and cessation of haemorrhage.
    Description
    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.
    Time Frame
    At immediate post-procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mahmoud K khairallah, master
    Phone
    +201149855332
    Email
    m.khairallah@aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mostafa H Othman, M.D.
    Organizational Affiliation
    Radiology Department in Assiut University Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    The Endovascular Management of Visceral Artery Aneurysms

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