Status:
COMPLETED
Arterial Stiffness, Blood Pressure and Cardiac Output Study
Lead Sponsor:
Rijnstate Hospital
Conditions:
Infrarenal Abdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Comparison of non-invasively obtained central blood pressure using SphygmoCor and invasively recorded central blood pressure in patients with an AAA that will be treated with EVAR.
Detailed Description
Primary objective of the first study: validation of non-invasive central pressure parameters in patients treated with EVAR against invasive measurements. Objectives of subsequent studies: Do non-inva...
Eligibility Criteria
Inclusion
- Male or female at least 18 years old;
- Informed consent form understood and signed and patient agrees to follow-up visits;
- Have a infrarenal abdominal aortic aneurysm (AAA) with maximum sac diameter ≥ 5.5cm, or an AAA ≥ 4.5 cm which has increased by \> 1.0 cm in the past year with a scheduled endovascular intervention
Exclusion
- Life expectancy \< 2 years;
- Psychiatric or other condition that may interfere with the study;
- Participating in another clinical study, interfering on outcomes;
- Irregular pulse;
- Presence of extensive peripheral arterial disease (ABI \< 0.9 or obstruction validated on imaging); dated less than 3 months prior to treatment
- Ruptured, leaking or mycotic aneurysm;
Key Trial Info
Start Date :
April 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03469388
Start Date
April 24 2017
End Date
December 31 2019
Last Update
March 11 2020
Active Locations (1)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800 TA