Evaluation of the radiation dose delivered to patients and staff during endovascular repair of aortic aneurysm in new generation imaging suites with image fusion guidance

Fusion Imaging-Guided EVAR Reduces Radiation - Results from a prospective multicentric study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN17506970

Enrollment

Registered

2017-11-08

Start date

2016-02-01

Completion date

Unknown

Last updated

2020-02-03

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

Conditions

Radiation effects Circulatory System Edovascular repair, Radiation effects

Interventions

This study is a prospective multicentric observational study. Six high volume aortic centers record data for all consecutive patients undergoing endovascular aneurysm repair (EVAR) with a bifurcated e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All consecutive patients undergoing endovascular aneurysm repair (EVAR) with a bifurcated endograft in the hybrid room with fusion imaging guidance 2. Aged 18 to 99 years old

Exclusion criteria

Exclusion criteria: 1. Patients treated in emergency 2. Patients with planned additionnal procedures (hypogastric embolization or iliac branch for the graft for example) 3. Patients refusing enrollment 4. Patients under the age of 18 yo or not able to give their consent

Design outcomes

Primary

Measure	Time frame
Dose-Area Product (DAP, in Gy.cm²) is measured using the internal dosimeter of the imaging equipment at the end of each procedure.	—

Secondary

Measure	Time frame
1. Cumulative Air-Kerma (CAK, in mGy) is measured using the internal dosimeter of the imaging equipment at the end of each procedure 2. Fluoroscopy Time (FT, min) is measured using the imaging equipment at the end of each procedure. 3. Duration of fusion imaging preparation (defined as time spent on the workstation from the start of the aorta analysis protocol to the launch of the fusion software) measured using a chronometer and reported by the investigators at the beginning of each procedure. 4. Duration of fusion imaging registration (time spent from the start of the bone registration to the switch from the bone mask to the vascular mask) measured using a chronometer and reported by the investigators at the beginning of each procedure. 5. Total Contrast Media Volume (cc) is measured manually by reporting the total volume of contrast medium injected to the patient during the case at the end of each procedure	—

Measure

Time frame

1. Cumulative Air-Kerma (CAK, in mGy) is measured using the internal dosimeter of the imaging equipment at the end of each procedure 2. Fluoroscopy Time (FT, min) is measured using the imaging equipment at the end of each procedure. 3. Duration of fusion imaging preparation (defined as time spent on the workstation from the start of the aorta analysis protocol to the launch of the fusion software) measured using a chronometer and reported by the investigators at the beginning of each procedure. 4. Duration of fusion imaging registration (time spent from the start of the bone registration to the switch from the bone mask to the vascular mask) measured using a chronometer and reported by the investigators at the beginning of each procedure. 5. Total Contrast Media Volume (cc) is measured manually by reporting the total volume of contrast medium injected to the patient during the case at the end of each procedure

—

Countries

France, Japan, United Kingdom, United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026