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

Jena University Hospital50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Occlusive Disease

Interventions

AngiographyDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital

Jena, Thuringia, Germany

Outcomes

Primary Outcomes

Degree of stenosis

Calculation of maximum grade of stenosis

Time frame: during intervention

Secondary Outcomes

Image quality

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

Time frame: 2 weeks

occurence of adverse events

Complications documted within 24 hours and pain scale during intervention

Time frame: 24 hours

Data from ClinicalTrials.gov

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