The effect and usefullness of yearly standardised imaging surveillance in patients that underwent endovascular repair of an asymptomatic abdominal aortic aneurysm.

Observing a Decade of Yearly Standardised Surveillance in EVAR-patients with Ultrasound or CT-Scan.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28430

Enrollment

1997

Registered

2018-04-05

Start date

2018-07-01

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

Abdominal aortic aneurysm, imaging surveillance, endovacular aortic repair Abdominaal aorta aneurysma, standaard beeldvorming, endovasculaire aorta ingreep

Interventions

standardised imaging surveillance

Eligibility

Inclusion criteria

Inclusion criteria: - Age above 17 years - Patients that underwent EVAR between 2007 and 2012 - Patient with an initial postoperative CTA within 60 days after EVAR - Patients with an asymptomatic infrarenal abdominal aortic aneurysm

Exclusion criteria

Exclusion criteria: - Connective tissue disease - Patients that objected to their retrospective data being used

Design outcomes

Primary

Measure	Time frame
the main outcome parameters are reinterventions and survival stratified for patients with and without yearly imaging surveillance during 6-11 years follow-up (in patient with a normal initial postoperative CTA)	—

Secondary

Measure	Time frame
- To assess type I, type II, type III and type IV endoleak, graft or outflow (iliac) occlusion, aneurysm rupture, endograft infection stratified for patients with complete and incomplete yearly standardised imaging surveillance (and a normal initial postoperative CTA). -To assess reintervention free survival stratified for patients with complete and incomplete yearly standardised imaging surveillance (and a normal initial postoperative CTA). - To assess if there is a difference in the number of patients with aneurysm rupture stratified for patients with complete and incomplete yearly standardised imaging surveillance (and a normal initial postoperative CTA). - To assess if there is a difference in the number of reinterventions or mortality between follow-up imaging with CTA or DUS. - To assess if there is a difference in costs stratified for patients with complete and incomplete yearly standardised imaging surveillance (and a normal initial postoperative CTA).	—

Measure

Time frame

- To assess type I, type II, type III and type IV endoleak, graft or outflow (iliac) occlusion, aneurysm rupture, endograft infection stratified for patients with complete and incomplete yearly standardised imaging surveillance (and a normal initial postoperative CTA). -To assess reintervention free survival stratified for patients with complete and incomplete yearly standardised imaging surveillance (and a normal initial postoperative CTA). - To assess if there is a difference in the number of patients with aneurysm rupture stratified for patients with complete and incomplete yearly standardised imaging surveillance (and a normal initial postoperative CTA). - To assess if there is a difference in the number of reinterventions or mortality between follow-up imaging with CTA or DUS. - To assess if there is a difference in costs stratified for patients with complete and incomplete yearly standardised imaging surveillance (and a normal initial postoperative CTA).

—

Contacts

Public ContactR. Balm

Academic Medical Center (AMC), Department of Vascular Surgery G4-111.1, P.O. Box 22660

r.balm@amc.nl+31 (0)20 5667832

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)