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