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

Study Overview
=================
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.

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

Conditions
-----------------
Peripheral Arterial Occlusive Disease

Intervention / Treatment
-----------------
* Device: Angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The randomization that allocates the patient either in the study arm (CO2) or in the control arm (iodine-CM) will occur right before angiography. Stenosis graduation and length will be measured after diagnostic angiography and before intervention. The interventional angiography will be conducted with the opposed contrast media used for diagnostic angiography. If contrast media containing iodine was used for diagnostic angiography, CO2 must be used for interventional angiography and if CO2 was applied for diagnostic angiography, contrast media containing iodine must be used for interventional angiography. 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CO2 first/ iodine CM second<br>CO2-enhanced angiography | Device: Angiography<br>* 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.<br>|
| Active Comparator: iodine CM first/ CO2 second<br>iodine contrast media-enhanced angiography | Device: Angiography<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of stenosis | Calculation of maximum grade of stenosis | during intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality | Image quality assessed by blinded radiologists who did not perform the angiographic intervention. | 2 weeks | 
| occurence of adverse events | Complications documted within 24 hours and pain scale during intervention | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CO2, angiography, peripheral occlusion disease, contrast medium, carbon dioxid enhanced angiography