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

NCT05590182 | Completed

• 1 other identifier: 5168-05/17
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Occlusive Disease

Keywords

CO2; angiography; peripheral occlusion disease; contrast medium; carbon dioxid enhanced angiography

Outcome Measures

Primary Outcomes (1)

• Degree of stenosis

  Calculation of maximum grade of stenosis

  during intervention

Secondary Outcomes (2)

• Image quality

  2 weeks

• occurence of adverse events

  24 hours

Study Arms (2)

CO2 first/ iodine CM second

ACTIVE COMPARATOR

CO2-enhanced angiography

Device: Angiography

iodine CM first/ CO2 second

ACTIVE COMPARATOR

iodine contrast media-enhanced angiography

Device: Angiography

Interventions

Angiography DEVICE

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.

CO2 first/ iodine CM second; iodine CM first/ CO2 second

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jena University Hospital: lead
• AngioDroid s.r.l., Bologna (Italy): collaborator

Study Sites (1)

University Hospital

Jena, Thuringia, 07747, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Interventions

Angiography

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular

Study Officials

• Ulf Teichgräber, Prof. Dr. med.

  University Hospital Jena, Radiology Department, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Interventional Radiology,

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: October 21, 2022
• Study Start: September 1, 2017
• Primary Completion: July 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

DE (1)