Carbon Dioxide Guided Angiography in Endovascular Abdominal Aortic Aneurysm Repair

NCT04444999 | Unknown

• 1 other identifier: MD.19.11.248 - 2019/11/01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Endovascular aneurysm repair (EVAR) has lower short-term morbidity and mortality than open surgery. Intra-arterial contrast agents are an important component of successful EVAR as the tool of choice for preoperative evaluation of aortic aneurysm morphology as well as precise sizing and intraoperative visualization of the ostia of the renal and hypogastric arteries for graft replacement. Although iodinated contrast (IC) is overwhelmingly the most common contrast agent, the perioperative use of IC agents is not recommended in patients with renal dysfunction or allergies to IC The aim of this study was to evaluate feasibility, efficacy and safety of carbon dioxide (CO2) digital subtraction angiography (DSA) to guide endovascular aneurysm repair (EVAR) in a cohort of patients with abdominal aortic aneurysm

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (3)

• Validity of Carbon Dioxide angiography in Visualizing of Renal and hypogastric arteries.

  Visualizing of Renal and hypogastric arteries.

  6 months

• Validity of Carbon Dioxide angiography in Visualizing Neck of the aneurysm measurements.

  measuring the supra renal and infra renal neck measurements

  6 months

• Validity of Carbon Dioxide angiography in Visualizing Endoleaks

  Endoleaks occur when blood leaks back into an aneurysm sac following an endovascular aneurysm repair (EVAR) procedure-one of the procedure's most common complications.

  6 months

Secondary Outcomes (1)

• Safety of Carbon Dioxide angiography at Endovascular aortic aneurysm repair

  6 months

Study Arms (1)

Endovascular abdominal aortic aneurysm repair

EXPERIMENTAL

a type of endovascular surgery used to treat pathology of the aorta, most commonly an abdominal aortic aneurysm (AAA).

Procedure: Carbon Dioxide Angiography

Interventions

Carbon Dioxide Angiography PROCEDURE

• Automated carbon dioxide angiography: Patients are placed in the Trendelenburg position with the feet elevated of 10 º degrees. Carbon Dioxide automatic injection will be performed by digital Angiodroid injection system

Endovascular abdominal aortic aneurysm repair

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 18 years old. Abdominal Aortic above Aneurysm candidate for EVAR

You may not qualify if:

• previous abdominal aortic surgery, , mycotic aneurysm and secondary intervention

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura

Al Mansurah, Mansoura University, 35111, Egypt

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Mosaad A Soliman, P.h.D

CONTACT

01001535711; soliman_mosaad@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: carbon dioxide (CO2) digital subtraction angiography (DSA) to guide endovascular aneurysm repair (EVAR(

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: June 24, 2020
• Study Start: November 1, 2019
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)