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

Not Applicable

Completed

• Conditions: Peripheral Arterial Occlusive Disease
• Interventions: Device: Angiography

• Registration Number: NCT05590182
• Lead Sponsor: Jena University Hospital

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.

Study Timeline

• Study First Submitted: 2017-07-17
• Study Start: 2017-09-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-10-01
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-19
• Last Update Submitted: 2022-10-19
• Study First Posted: 2022-10-21
• Last Update Posted: 2022-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age > 18 years
• Male, female
• Patients with indication for percutaneous transluminal angioplasty of iliacal- or femoropopliteal arteries

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CO2 first/ iodine CM second	Angiography	CO2-enhanced angiography
iodine CM first/ CO2 second	Angiography	iodine contrast media-enhanced angiography

Primary Outcome Measures

Name	Time	Method
Degree of stenosis	during intervention	Calculation of maximum grade of stenosis

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital; 🇩🇪 Jena, Thuringia, Germany