Clinical trial NCT05590182: CO2-Angiography-Study to Evaluate Diagnostic and Safety to Patients With Peripher Arterial Stenotic or Occlusive Disease.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Occlusive Disease
Keywords: CO2
angiography
peripheral occlusion disease
contrast medium
carbon dioxid enhanced angiography
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: AngioDroid s.r.l., Bologna (Italy)
First posted: 2022-10-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Degree of stenosis
timeFrame: during intervention
Secondary outcomes:
measure: Image quality
timeFrame: 2 weeks
measure: occurence of adverse events
timeFrame: 24 hours
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University Hospital
state: Thuringia
Study officials:
affiliation: University Hospital Jena, Radiology Department, Germany
name: Ulf Teichgräber, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: