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

Peripheral Arterial Occlusive Disease Clinical Trial

— ACDA-RCT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05590182
• Other study ID #: 5168-05/17
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2022
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease

Intervention

Device:
• Angiography
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.

Locations

Country	Name	City	State
Germany	University Hospital	Jena	Thuringia

Sponsors (2)

Lead Sponsor	Collaborator
Jena University Hospital	AngioDroid s.r.l., Bologna (Italy)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of stenosis	Calculation of maximum grade of stenosis	during intervention
Secondary	Image quality	Image quality assessed by blinded radiologists who did not perform the angiographic intervention.	2 weeks
Secondary	occurence of adverse events	Complications documted within 24 hours and pain scale during intervention	24 hours