Aortoiliac Occlusive Disease Clinical Trial
Official title:
Carbon Dioxide Versus Iodine Contrast Medium for Endovascular Revascularization of Aortoiliac Occlusive Disease: A Two Center Randomized Controlled Trial
Verified date | July 2020 |
Source | Zagazig University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | January 15, 2020 |
Est. primary completion date | July 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Zagazig University |
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. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | technical success rate | surgical results with completion of the intended procedure. | immediate post operative | |
Secondary | Incidence of Procedure-related complications . | defined as the freedom from procedural complications (Procedure-related complications were the incidence of cardiac death, myocardial infarction, stroke, major amputation, non-occlusive mesenteric ischemia, extended hospitalization (> 24 hours) as a consequence of CO2-guided treatment, hematomas, pseudo-aneurysms, perforations, contrast induced nephropathy (CIN), target lesion revascularization and postoperative death within 3 months of surgery,) | 1year follow up |
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