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LSPEAS

Longitudinal study to pulsatility and expansion in aortic stent grafts

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21575
Enrollment
20
Registered
2013-11-22
Start date
2014-01-01
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 aneurysm stent graft

Interventions

Present practise is that all AAA patients undergo one abdominal aorta CTA pre-operatively, and receive ultrasound duplex scanning and plain abdominal X-ray at discharge, 3 months, 6 months and yearly
CT-scans are performed on indication. Patients included in this study receive an ECG-gated CTA pre-intervention plus three ECG-gated CTAs post-operatively: at discharge, after one month, and after six

Sponsors

Vascutek Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Asymptomatic AAA - Age > 70 - Indication for AAA treatment according to standard practise - Anatomy suitable for Anaconda and/or Endurant endoprosthesis

Exclusion criteria

Exclusion criteria: - No informed consent obtained - Contrast allergy

Design outcomes

Primary

MeasureTime frame
To gain insight in the parameters that influence the success and failure of the proximal fixation and/or sealing of the endoprosthesis. More practically, this leads to the question of how the diameter of the stent rings changes during the cardiac cycle (pulsatility), and how the diameter changes over a period of several months (expansion)?

Secondary

MeasureTime frame
How does the estimated vessel compliance change over a period of several months? What can we learn from the difference in results between the two types of stents? Can we observe other kinds of motion that change over time, or differ significantly between the two types of stent grafts?

Contacts

Public ContactR.H. Geelkerken

Medisch Spectrum Twente Postbus 50000

researchbureau.heelkunde@ziekenhuis-mst.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)