Juxtarenal Aortic Aneurysm
Conditions
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
Interventions
PROCEDUREEndovascular Repair of Juxtarenal Aortic Aneurysm
1. 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.
Sponsors
Assiut University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective cross sectional study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactKhaled M Awad, Master
Backup ContactAshraf M Abo Bakr, MD
Outcome results
None listed