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Completed

NCT Number: NCT05590182

CO2-Angiography-Study to Evaluate Diagnostic and Safety to Patients With Peripher Arterial Stenotic or Occlusive Disease.

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Jena, Thuringia, 07747, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiography

Device

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.

Primary outcomes

  1. Degree of stenosis

    Time frame: during intervention

    Calculation of maximum grade of stenosis

Secondary outcomes

  1. Image quality

    Time frame: 2 weeks

    Image quality assessed by blinded radiologists who did not perform the angiographic intervention.

  2. occurence of adverse events

    Time frame: 24 hours

    Complications documted within 24 hours and pain scale during intervention

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Collaborators

  • AngioDroid s.r.l., Bologna (Italy)

Registry information

Official study 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

Acronym: ACDA-RCT

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 21, 2022
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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