Endovascular Repair of Juxtarenal Aortic Aneurysm

NCT04252079 | Unknown

• 1 other identifier: Aortic aneurysm repair
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Juxtarenal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• 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

• 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.

  One year

Study Arms (1)

We compare different endovascular techniques as an alternative

OTHER

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

Procedure: Endovascular Repair of Juxtarenal Aortic Aneurysm

Interventions

Endovascular Repair of Juxtarenal Aortic Aneurysm PROCEDURE

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.

We compare different endovascular techniques as an alternative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 8024454 BACKGROUND

• 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.

  PMID: 10493476 BACKGROUND

• 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.

  PMID: 29268916 BACKGROUND

• 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.

  PMID: 21215940 BACKGROUND

• 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.

  PMID: 21092788 BACKGROUND

• 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.

  PMID: 26898979 BACKGROUND

• 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.

  PMID: 26792544 BACKGROUND

Study Officials

• Ashraf G Taha, MD

  Assistant professur Assiut University

  STUDY DIRECTOR

Central Study Contacts

Khaled M Awad, Master

CONTACT

01006797162; k.awad5@yahoo.com

Ashraf M Abo Bakr, MD

CONTACT

01005212168; Ashrafnagar@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Prospective cross sectional study

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: February 5, 2020
• Study Start: March 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 5, 2020

Record last verified: 2020-01