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

Jena University Hospital

Status: Completed

Conditions: Peripheral Arterial Occlusive Disease

Treatments: Device: Angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT05590182

5168-05/17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

CO2 first/ iodine CM second

Active Comparator group

Description:

CO2-enhanced angiography

Treatment:

Device: Angiography

iodine CM first/ CO2 second

Active Comparator group

Description:

iodine contrast media-enhanced angiography

Treatment:

Device: Angiography