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Carbon Dioxide Versus Iodine Contrast for Endovascular Revascularization of Aortoiliac Occlusive Disease

NCT04458714 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-07-07

No results posted yet for this study

Summary

From July 2015 to July 2018, 64 patients with aortoiliac occlusive disease who were eligible for endovascular treatment and lacked contraindications to either iodine contrast or carbon dioxide (CO2) were randomized into the carbon dioxide CO2 group(32) or iodine contrast medium(ICM) group(32) were subjected to aortoiliac angioplasty. The primary outcome was the quality of image as the sole contrast agent used in interventions. The secondary outcomes were technical success rate and the safety of procedure.

Conditions

  • Aortoiliac Occlusive Disease

Interventions

PROCEDURE

Aortoiliac angioplasty

In the CO2 arm we used manual injection of CO2 from a medicinal CO2 cylinder connected to a particle filter. Under water aspiration was used to prevent air contamination. Using a twenty mls syringe the required amount of CO2was aspirated using a three way tap and was followed my aspirating 3mls of saline to provide a fluid barrier. In the ICM arm the injection of contrast was done using 10-ml syringes with 5 mls of iodinated contrast media and 5 mls of saline solution per injection. The ICM used in all cases was Omnipaque 300 (Iohexol), a nonionic low osmolar contrast commonly in use in both hospitals.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2019-07-01
Completion
2020-01-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04458714 on ClinicalTrials.gov