Arterial Stiffness, Blood Pressure and Cardiac Output Study (ABC)

Rijnstate Hospital

Status: Completed

Conditions: Infrarenal Abdominal Aortic Aneurysm

Treatments: Diagnostic Test: Pulse wave analyses; central blood presaure parameters

Study type: Interventional

Funder types: Other

Identifiers

NCT03469388

NL57153.091.16 (Other Identifier)

2016-0820

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

elective EVAR patients

Experimental group

Description:

Elective EVAR patients will be included in one arm only

Treatment:

Diagnostic Test: Pulse wave analyses; central blood presaure parameters