University Hospital
Jena, Thuringia, 07747, Germany
NCT Number: NCT05590182
This randomized study focuses on the diagnostic quality and safety of CO2 application as contrast medium through an innovative injector of AngioDroid in angiography interventions in patients with peripheral arterial occlusive diseases.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Jena, Thuringia, 07747, Germany
CO2-angiography was used as an intra-arterial contrast agent since the 1970s particularly in patients who were hypersensitive to iodinated contrast material or whose renal function was compromised. It is in fact an effective and low-risk alternative to iodine-enhanced conventional angiography because it is not associated with nephrotoxicity or allergic reactions. The image quality influencing the diagnostic validity seems to be a restriction. Now, with the availability of high-resolution DSA and a reliable gas delivery system, CO2 angiography is more and more widely used for vascular imaging and endovascular procedures. Our study will specifically examine the image quality and safety of carbon dioxide gas as intra-arterial contrast agent using the innovative Artis Zeego Q angiography-system of Siemens Healthineers with the automated CO2-injection system of Angiodroid.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Randomization either in the study arm (CO2) or in the control arm (iodine-CM) occurs right before angiography. Stenosis graduation and length are measured after diagnostic angiography and before intervention. The calculated values through the software-quantification-tool, including also a final sequence of the distal outflow with the same contrast media used during intervention, are be compared and statistically analyzed.
A pain protocol to the current pain-situation is led by the present medical-laboratory assistant after administration of CO2 and iodine-CM during intervention.
Time frame: during intervention
Calculation of maximum grade of stenosis
Time frame: 2 weeks
Image quality assessed by blinded radiologists who did not perform the angiographic intervention.
Time frame: 24 hours
Complications documted within 24 hours and pain scale during intervention
Jena University Hospital
Other
Randomized-Controlled Study to Evaluate the Diagnostic Quality and Safety of Automated Carbon Dioxide Angiography (ACDA) With a Robot-supported Angiography System in Combination With a CO2-Injector System in Patients With Peripheral Arterial Occlusive Disease
Acronym: ACDA-RCT
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