An interventional study of Pulse wave analyses; central blood presaure parameters in Infrarenal Abdominal Aortic Aneurysm, sponsored by Rijnstate Hospital. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-11.
Sponsored by Rijnstate Hospital · Not applicable, Interventional, and Diagnostic
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.
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-invasive central parameters change over time after EVAR? What is the influence of intraluminal thrombus (presence, amount, configuration) on non-invasive central pressure parameters (and other obtained parameters of arterial stiffness)? Prospective study with consecutive, eligible subject enrollment. All subjects will undergo the Endovascular Aneurysm repair procedure with an endovascular device. Subjects will be followed procedurally, at 6-8 weeks and 1 year post implantation.
This study is a collaboration of the following departments of the Vascular Center in the Rijnstate Hospital Arnhem: Vascular Surgery, Interventional radiology, Internal Vascular Medicine, Cardiology.
Patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair and who meet the study eligibility criteria may be screened for enrollment in the study. Up to 20 subjects will be enrolled .
Pre-procedural high resolution, contrast-enhanced CT scan evaluation to determine anatomical eligibility for enrollment will be performed within three months of the study procedure, according to standard care. Following EC/IRB approval of the study and the written informed consent form, patients will be screened for eligibility. Following informed consent, clinical characteristics will be reported (from hospital records). Per-procedural PWA measurements will be performed simultaneously with intravascular pressure measurements pre-implantation and after completion of the endocasular implantation. Subjects will be followed at 30 days and 1 year post-implantation.
Exclusion Criteria:
Elective EVAR patients will be included in one arm only
Diagnostic Test: Pulse wave analyses; central blood presaure parameters
Pulse wave analyses; central blood presaure parameters
Also known as: Pulse wave velocity
central blood pressure
comparison of invasively recorded and non-invsively estimated central blood pressure
Time frame: one week
changes in arterial stiffness pre- and post EVAR
changes in arterial stiffness pre- and post EVAR
Time frame: 1 year
influence of thrombus on arterial stiffness
influence of thrombus on arterial stiffness
Time frame: 1 year
changes in arterial stiffness over time
changes in arterial stiffness over time
Time frame: 1 year
Plan to share: Undecided
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Rijnstate Hospital