Clinical Trials Directory

Trials / Unknown

UnknownNCT04252079

Endovascular Repair of Juxtarenal Aortic Aneurysm

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDUREEndovascular Repair of Juxtarenal Aortic Aneurysm1. History taking and clinical examination. 2. Preoperative Imaging CTA is the cross-sectional imaging modality of choice. 3. Preoperative evaluation a-Renal evaluation b\_ cardiac evaluation C-Pulmonary evaluation 4. Surgical techniques 1. 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. 2. 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.

Timeline

Start date
2020-03-01
Primary completion
2021-03-01
Completion
2021-09-01
First posted
2020-02-05
Last updated
2020-02-05

Source: ClinicalTrials.gov record NCT04252079. Inclusion in this directory is not an endorsement.