Infrarenal Abdominal Aortic Aneurysm
Conditions
Keywords
EVAR, central pressure, arterial stiffness, AAA, elective surgery
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-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.
Interventions
DIAGNOSTIC_TESTPulse wave analyses; central blood presaure parameters
Pulse wave analyses; central blood presaure parameters
Sponsors
Rijnstate Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
prospective,multidisciplinary single center study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female at least 18 years old; 2. Informed consent form understood and signed and patient agrees to follow-up visits; 3. 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 criteria
1. Life expectancy \< 2 years; 2. Psychiatric or other condition that may interfere with the study; 3. Participating in another clinical study, interfering on outcomes; 4. Irregular pulse; 5. Presence of extensive peripheral arterial disease (ABI \< 0.9 or obstruction validated on imaging); dated less than 3 months prior to treatment 6. Ruptured, leaking or mycotic aneurysm;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| central blood pressure | one week | comparison of invasively recorded and non-invsively estimated central blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in arterial stiffness pre- and post EVAR | 1 year | changes in arterial stiffness pre- and post EVAR |
| influence of thrombus on arterial stiffness | 1 year | influence of thrombus on arterial stiffness |
| changes in arterial stiffness over time | 1 year | changes in arterial stiffness over time |
Countries
Netherlands
Outcome results
None listed