Endovascular Repair of Juxtarenal Aortic Aneurysm

Not Applicable

• Conditions: Juxtarenal Aortic Aneurysm
• Interventions: Procedure: Endovascular Repair of Juxtarenal Aortic Aneurysm

• Registration Number: NCT04252079
• Lead Sponsor: Assiut University

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

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-18
• Study First Submitted QC: 2020-01-30
• Last Update Submitted: 2020-01-30
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Study Start: 2020-03-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
We compare different endovascular techniques as an alternative	Endovascular Repair of Juxtarenal Aortic Aneurysm	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

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be clinical success .	One year	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	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.