Abdominal aortic aneurysm Circulatory System Abdominal aortic aneurysm, without mention of rupture
Conditions
Interventions
Current intervention as of 24/01/2022:
Participants will be randomised via the KCTU web-based randomisation system. Participants will be randomised to Cydar-EV image fusion for guidance or standard im
Sponsors
King's College London
Cydar Medical Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 24/01/2022: 1. Clinical diagnosis of abdominal aortic aneurysm (AAA) or thoracoabdominal aortic aneurysm (TAAA) suitable for endovascular treatment, as determined by CT imaging and multidisciplinary review by treating team 2. Fit for endovascular repair as determined by the operating team 3. CT imaging must be in accordance with ‘Cydar EV: Instructions for Use’ i.e. scans should have the same slice thickness and intervals as the original scan acquisition, must not have any missing slices or discontinuities, must include the pelvis and whole vertebrae including the spinous processes and must not use gantry tilt (this will be done post-consent) 4. Written informed consent (patients lacking capacity or unable to speak English will not be enrolled) 5. Age 18 years and above at the time of consent Previous participant inclusion criteria: 1. Clinical diagnosis of abdominal aortic aneurysm (AAA) or thoracoabdominal aortic aneurysm (TAAA) suitable for endovascular treatment, as determined by CT imaging and multidisciplinary review by treating team 2. Fit for endovascular repair as determined by the operating team 3. CT imaging must be in accordance with ‘Cydar EV: Instructions for Use’ i.e. scans should have the same slice thickness and intervals as the original scan acquisition, must not have any missing slices or discontinuities, must include the pelvis and whole vertebrae including the spinous processes and must not use gantry tilt (this will be done post-consent) 4. Written informed consent (patients lacking capacity will not be enrolled) 5. Age 18 years and above at the time of consent
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 24/01/2022: Patients unable to provide written informed consent _____ Previous participant exclusion criteria: Patients with known connective tissue disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure time, measured as the time between insertion of the first wire (after percutaneous access achieved, if applicable) at the beginning of the endovascular procedure to the last frame of the completion angiogram. This will be recorded (in minutes) at the time of the procedure by the local research team. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 24/01/2022: 1. Procedural efficiency: 1.1. Anaesthetic duration – the time between the beginning of induction and the end of emergence. This will be documented at the time of the procedure by the local research team in minutes. 1.2. X-ray dose per procedure – fluoroscopy time (FT) (seconds), dose area product (DAP) (Gy.cm2) and cumulative air kerma (CAK) (mGy) should be recorded and documented at the time of the procedure by the local research team. The imaging system used should also be recorded. 1.3. Contrast dose per procedure – the volume (ml) and concentration (mgI/ml) of the iodinated contrast material used should be recorded by the local research team at the time of the procedure in minutes. 1.4. Consumable use in the operating theatre for endovascular aortic aneurysm repair – the name of device, unit and quantity used, blood products used; details to be completed by nurse in the operating theatre or research nurse at the time of the procedure using a Source Data Worksheet. 2. Technical success: 2.1. Proximal and distal seal zone at least 10 mm and no evidence of endoleak. This will be documented by the imaging CoreLab team on review of the CT images acquired postoperatively and at 4-12 weeks and at 52 weeks. 3. Patient outcomes: 3.1. Length of ITU/HDU admission – date and time from admission to date and time of discharge from ITU/HDU; documented by the local research team during the time of admission; ITU and HDU admissions should be documented separately 3.2. Postoperative length of hospital stay – date of procedure to date of discharge from hospital (nights); documented by the local research team during the time of admission. 3.3. 30-day mortality – death of the participant within 30 days of the primary procedure; documented by the local research team; to include date of death (dd/mm/yy) and cause. 3.4. Re-intervention – any procedure open surgical or endovascular undertaken within 1 year of the pr | — |
Countries
England, United Kingdom
Contacts
Public ContactIzabela Pilecka
Outcome results
None listed