Contrast Medium Reduction with AlluraClarity for Iliac/Peripheral and EVAR procedures

Contrast Medium Reduction with AlluraClarity for Iliac/Peripheral and EVAR procedures - Contrast Medium Reduction with AlluraClarity (COMER)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47473

Enrollment

260

Registered

2019-05-15

Start date

2018-03-12

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endovascular aneurysm repair and iliac/peripheral procedure

Interventions

not applicable

AlluraClarity

Contrast Medium

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Subject will be undergoing an EVAR or iliac/peripheral procedure * Subject is 18 years of age or older

Exclusion criteria

Exclusion criteria: * Subject with contrast allergies * Subject with severe kidney disease (e-GFR

Design outcomes

Primary

Measure	Time frame
The following endpoints will be measured in Phase 2: - The amount of contrast used for each subject will be measured as contrast medium volume, flow, concentration, iodine delivery rate, iodine load. - Procedure complexity is quantified as fluoroscopy time, number of DSA runs and number of DSA images - Physician switch-backs will be quantified by the amount of DSA runs performed with control settings during a procedure which is supposed to be performed with study settings in phase 2. - Patient radiation dose will be quantified as DAP fluoro, DAP exposure, total DAP, and Air Kerma	—

Measure

Time frame

The following endpoints will be measured in Phase 2: - The amount of contrast used for each subject will be measured as contrast medium volume, flow, concentration, iodine delivery rate, iodine load. - Procedure complexity is quantified as fluoroscopy time, number of DSA runs and number of DSA images - Physician switch-backs will be quantified by the amount of DSA runs performed with control settings during a procedure which is supposed to be performed with study settings in phase 2. - Patient radiation dose will be quantified as DAP fluoro, DAP exposure, total DAP, and Air Kerma

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)