Endovascular Repair of Juxtarenal Aortic Aneurysm
Primary Purpose
Juxtarenal Aortic Aneurysm
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endovascular Repair of Juxtarenal Aortic Aneurysm
Sponsored by
About this trial
This is an interventional treatment trial for Juxtarenal Aortic Aneurysm
Eligibility Criteria
Inclusion Criteria:
• Subject is ≥18 years old
- Subject is scheduled for treatment of the juxtarenal aortic aneurysm with a short infrarenal neck aortic neck length <15 mm, neck angulation >60%, conical neck) (i.e. denovo cases).
- Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
- Subject has provided written informed consent.
Exclusion Criteria:
Subject is participating in a concurrent study which may confound study results
- Subject has a life expectancy ≤1 year
Subject has an aneurysm that is:
- Mycotic
- Inflammatory
- Pseudoaneurysm
- Subject requires emergent aneurysm treatment, for example, trauma or rupture
- Subject has previously undergone surgical treatment for abdominal aortic aneurysm
- Subject is a female of childbearing potential in whom pregnancy cannot be excluded
- Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
We compare different endovascular techniques as an alternative
Arm Description
We compare different endovascular techniques as an alternative to surgical reconstruction to repair JAAS regarding ; success rates, 30-day mortality, endoleak events secondary intervention rates
Outcomes
Primary Outcome Measures
The primary outcome measure will be clinical success .
Clinical success will be evaluated by Measurment of blood pressure by sphygmomanometer in mmhg Serum creatinine level in mg/dL
One year patency of the endovascular graft
One year patency will be assessed by CT angiography ( if it is patent or not).
CT angiography can detect successful deployment of the endovascular device at the intended location or post endograft complications as type I or III endoleak , graft thrombosis, aneurysm expansion , aneurysm rupture.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04252079
Brief Title
Endovascular Repair of Juxtarenal Aortic Aneurysm
Official Title
Endovascular Repair of Juxtarenal Aortic Aneurysm
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
September 1, 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
The investigators compare different endovascular techniques as an alternative to surgical reconstruction to repair JAAS regarding ; success rates, 30-day mortality,endoleak events secondary intervention rates
Detailed Description
Aortic disease is the direct cause of close to 10000 deaths annually in the United States. 1
Aneurysmal disease can affect any segment of the aorta, from the aortic root to the aortic bifurcation. Juxtarenal Aortic Aneurysms (JAA) (where a specialty designed custom -made device (endograft)which has holes, or fenestrations ,on the graft body to maintain the patency of the visceral arteries) account for approximately 15% of abdominal aortic aneurysms.2
Successful aortic aneurysm treatment depends on either open replacement or endovascular exclusion of the aneurysmal segment with healthy artery proximal and distal to the repair.
The decision to treat an AAA is based on the associated risk of treatment, the risk of aneurysm rupture, the patient's life expectancy, and patient preference.
The primary determinant of rupture risk is maximum aneurysm diameter, with negligible rupture risk in aneurysms <4cm in diameter compared with aneurysms >8 cm . 3, 4.
The Society for Vascular Surgery recommends repair for all patients of acceptable perioperative risk with an AAA ≥5.5 cm in diameter as well as all patients with saccular and symptomatic aneurysms.5 ,6
These guidelines also suggest repair for women at a diameter of 5.0 cm.
Fenestrated Endovascular Aneurysm Repair (FEVAR) and Chimney Endovascular Aneurysm Repair (CHEVAR)are both effective methods to treat JAAs
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juxtarenal Aortic Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cross sectional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
We compare different endovascular techniques as an alternative
Arm Type
Other
Arm Description
We compare different endovascular techniques as an alternative to surgical reconstruction to repair JAAS regarding ; success rates, 30-day mortality, endoleak events secondary intervention rates
Intervention Type
Procedure
Intervention Name(s)
Endovascular Repair of Juxtarenal Aortic Aneurysm
Intervention Description
History taking and clinical examination.
Preoperative Imaging
CTA is the cross-sectional imaging modality of choice.
Preoperative evaluation
a-Renal evaluation
b_ cardiac evaluation C-Pulmonary evaluation
Surgical techniques
Anesthesia The use of general anesthesia due to the duration of the procedures and the necessity to control patient breathing to allow precise imaging and accurate device deployment.
Intra operative imaging A "hybrid" operating room with high-quality fixed imaging is needed for the performance of FEVAR.
C-Device delivery and deployment all FEVAR procedures begin with access of the femoral arteries by either open or percutaneous technique.
Primary Outcome Measure Information:
Title
The primary outcome measure will be clinical success .
Description
Clinical success will be evaluated by Measurment of blood pressure by sphygmomanometer in mmhg Serum creatinine level in mg/dL
Time Frame
One year
Title
One year patency of the endovascular graft
Description
One year patency will be assessed by CT angiography ( if it is patent or not).
CT angiography can detect successful deployment of the endovascular device at the intended location or post endograft complications as type I or III endoleak , graft thrombosis, aneurysm expansion , aneurysm rupture.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Subject is ≥18 years old
Subject is scheduled for treatment of the juxtarenal aortic aneurysm with a short infrarenal neck aortic neck length <15 mm, neck angulation >60%, conical neck) (i.e. denovo cases).
Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
Subject has provided written informed consent.
Exclusion Criteria:
Subject is participating in a concurrent study which may confound study results
Subject has a life expectancy ≤1 year
Subject has an aneurysm that is:
Mycotic
Inflammatory
Pseudoaneurysm
Subject requires emergent aneurysm treatment, for example, trauma or rupture
Subject has previously undergone surgical treatment for abdominal aortic aneurysm
Subject is a female of childbearing potential in whom pregnancy cannot be excluded
Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled M Awad, Master
Phone
01006797162
Email
k.awad5@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ashraf M Abo Bakr, MD
Phone
01005212168
Email
Ashrafnagar@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf G Taha, MD
Organizational Affiliation
Assistant professur Assiut University
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
8024454
Citation
Taylor SM, Mills JL, Fujitani RM. The juxtarenal abdominal aortic aneurysm. A more common problem than previously realized? Arch Surg. 1994 Jul;129(7):734-7. doi: 10.1001/archsurg.1994.01420310066011.
Results Reference
background
PubMed Identifier
10493476
Citation
Brown LC, Powell JT. Risk factors for aneurysm rupture in patients kept under ultrasound surveillance. UK Small Aneurysm Trial Participants. Ann Surg. 1999 Sep;230(3):289-96; discussion 296-7. doi: 10.1097/00000658-199909000-00002.
Results Reference
background
PubMed Identifier
29268916
Citation
Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.
Results Reference
background
PubMed Identifier
21215940
Citation
Moll FL, Powell JT, Fraedrich G, Verzini F, Haulon S, Waltham M, van Herwaarden JA, Holt PJ, van Keulen JW, Rantner B, Schlosser FJ, Setacci F, Ricco JB; European Society for Vascular Surgery. Management of abdominal aortic aneurysms clinical practice guidelines of the European society for vascular surgery. Eur J Vasc Endovasc Surg. 2011 Jan;41 Suppl 1:S1-S58. doi: 10.1016/j.ejvs.2010.09.011. No abstract available.
Results Reference
background
PubMed Identifier
21092788
Citation
Greenberg R, Eagleton M, Mastracci T. Branched endografts for thoracoabdominal aneurysms. J Thorac Cardiovasc Surg. 2010 Dec;140(6 Suppl):S171-8. doi: 10.1016/j.jtcvs.2010.07.061.
Results Reference
background
PubMed Identifier
26898979
Citation
Coselli JS, LeMaire SA, Preventza O, de la Cruz KI, Cooley DA, Price MD, Stolz AP, Green SY, Arredondo CN, Rosengart TK. Outcomes of 3309 thoracoabdominal aortic aneurysm repairs. J Thorac Cardiovasc Surg. 2016 May;151(5):1323-37. doi: 10.1016/j.jtcvs.2015.12.050. Epub 2016 Jan 14.
Results Reference
background
PubMed Identifier
26792544
Citation
Eagleton MJ, Follansbee M, Wolski K, Mastracci T, Kuramochi Y. Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms. J Vasc Surg. 2016 Apr;63(4):930-42. doi: 10.1016/j.jvs.2015.10.095. Epub 2016 Jan 11.
Results Reference
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Endovascular Repair of Juxtarenal Aortic Aneurysm
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