Peripheral Arterial Occlusive Disease
Conditions
Keywords
CO2, angiography, peripheral occlusion disease, contrast medium, carbon dioxid enhanced angiography
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAngiography
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.
Sponsors
AngioDroid s.r.l., Bologna (Italy)
Jena University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The randomization that allocates the patient either in the study arm (CO2) or in the control arm (iodine-CM) will occur right before angiography. Stenosis graduation and length will be measured after diagnostic angiography and before intervention. The interventional angiography will be conducted with the opposed contrast media used for diagnostic angiography. If contrast media containing iodine was used for diagnostic angiography, CO2 must be used for interventional angiography and if CO2 was applied for diagnostic angiography, contrast media containing iodine must be used for interventional angiography. 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Male, female * Patients with indication for percutaneous transluminal angioplasty of iliacal- or femoropopliteal arteries
Exclusion criteria
* Children and adolescents \< 18 years * Diagnostic angiography, CT- or MRI-angiography during the past 3 months * Patients with reduced renal function (S-creatinine \> 1,2 mg/dl) * Incapacitated patients * Severe COPD * Known atrium- or ventricular septal defect with right-left-shunt * Current participation in other interventional studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of stenosis | during intervention | Calculation of maximum grade of stenosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Image quality | 2 weeks | Image quality assessed by blinded radiologists who did not perform the angiographic intervention. |
| occurence of adverse events | 24 hours | Complications documted within 24 hours and pain scale during intervention |
Countries
Germany
Outcome results
None listed