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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juxtarenal Aortic Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 18, 2020
    Last Updated
    January 30, 2020
    Sponsor
    Assiut University
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    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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