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

NCT04458714 | Completed

• 1 other identifier: zu-irb#6036/16-3-2015
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

CO2 angiography; angioplasty; aortoiliac occlusive disease

Outcome Measures

Primary Outcomes (1)

• quality of image as the sole contrast agent to perform the needed interventions: Likert rating scale

  Imaging from all cases were analyzed on conclusion of the study. The images were reviewed by two independent observers (radiologists with \> 5 years of experience in performing endovascular procedures) blinded to treatment arm. Image quality was assessed using Likert rating scale ranging from 1 (very poor) to 5 (very good) for each image.

  on conclusion of patient recruitment , image quality was aseessed within 12 weeks

Secondary Outcomes (2)

• technical success rate

  immediate post operative

• Incidence of Procedure-related complications .

  1year follow up

Study Arms (2)

CO2 group (treatment arm)

ACTIVE COMPARATOR

This arm included 32 patients who were randomized for using CO2 as the contrast medium for aortoiliac angiolplasty.

Procedure: Aortoiliac angioplasty

ICM group (control arm)

ACTIVE COMPARATOR

This arm involved 32 patients who were randomized for using iodine contrast medium (ICM) for aortoiliac angiolplasty.

Procedure: Aortoiliac angioplasty

Interventions

Aortoiliac angioplasty PROCEDURE

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.

CO2 group (treatment arm); ICM group (control arm)

Eligibility Criteria

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

You may qualify if:

• Patients with aortoiliac arteries atherosclerotic disease (with arterial atherosclerotic disease classified as Trans-Atlantic Inter-Society Consensus (TASC) A, B and C, (classified by CT angiography)
• Patients with good distal runoff
• Patients suitable for either types of contrast ICM or CO2 (No history of allergy to contrast and normal kidney functions)

You may not qualify if:

• Patients with TASC D aortoiliac lesions
• Patients requiring femoral endartectomy
• Patient s with significant multilevel distal disease
• Patients suffering from severe chronic obstructive lung disease, chronic kidney failure, heart failure, or pregnancy.
• Patients younger than 18 years

Sponsors & Collaborators

• Zagazig University: lead

Related Publications (3)

• de Almeida Mendes C, de Arruda Martins A, Teivelis MP, Kuzniec S, Nishinari K, Krutman M, Halpern H, Wolosker N. Carbon dioxide is a cost-effective contrast medium to guide revascularization of TASC A and TASC B femoropopliteal occlusive disease. Ann Vasc Surg. 2014 Aug;28(6):1473-8. doi: 10.1016/j.avsg.2014.03.021. Epub 2014 Apr 3.

  PMID: 24704050 BACKGROUND

• Fujihara M, Kawasaki D, Shintani Y, Fukunaga M, Nakama T, Koshida R, Higashimori A, Yokoi Y; CO2 Angiography Registry Investigators. Endovascular therapy by CO2 angiography to prevent contrast-induced nephropathy in patients with chronic kidney disease: a prospective multicenter trial of CO2 angiography registry. Catheter Cardiovasc Interv. 2015 Apr;85(5):870-7. doi: 10.1002/ccd.25722. Epub 2014 Nov 21.

  PMID: 25380326 BACKGROUND

• Sharafuddin MJ, Marjan AE. Current status of carbon dioxide angiography. J Vasc Surg. 2017 Aug;66(2):618-637. doi: 10.1016/j.jvs.2017.03.446.

  PMID: 28735955 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients who agreed were asked to sign an informed consent. After patient data input was done, randomization was computer generated in the vascular surgery department in Zagazig university hospitals. Computer generated random numbers were created with the use of randomly permuted blocks with two block sizes; after which they were secured in consecutive numbered envelopes and group allocation was independent of time and person delivering the treatment. Single blinding was used to recruit the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professorof vascular surgery

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: July 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: January 15, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share