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Non-invasive Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm (VBA)

Non-invasive Peri- and Postoperative Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03493074
Acronym
VBA
Enrollment
30
Registered
2018-04-10
Start date
2018-04-08
Completion date
2021-08-30
Last updated
2020-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm, Cardiovascular Diseases

Brief summary

This study evaluates a novel noninvasive method to dynamically monitor the effect of abdominal aortic aneurysm (AAA) and endovascular treatment of AAA (EVAR) on arterial pulse wave

Detailed description

Abdominal aortic aneurysm (AAA) develops slowly and degeneratively (increasing diameter, wall tension, thinning and decreased wall strength, altered compliance) which affects the aortic pressure and wave reflection. In 50% of cases, AAA rupture may lead to death and 50% of the remaining patients referred to hospital die. This results in high costs and preventable loss of lives. AAA can also be detected by pulse wave (PW) analysis. which could enable development of easy to use, affordable and accurate methodology for the detection of AAAs. The measurement system used in the present study is capable of wireless recording of PWs from several different locations utilizing two different sensor modalities (blood-volume related photoplethysmographic (PPG) PWs and dynamic blood pressure PWs). The objective is to study PWs in the detection of AAA and the effects of endovascular repair (EVAR) and whether adverse effects (i.e. endograft failure) can be detected. It is hypothesized that AAA and failure of the operation can be detected by PW features, especially by printed flexible sensors which will improve the usability, patient comfort and safety (hygiene). The technology could make it possible to screen AAAs at lower costs even in the municipal health centers or by the patients themselves, at similar accuracy, without skilled personnel operating the diagnostic devices and therefore improve the cost effectiveness of AAA screening resulting in significant savings, resource reallocation in the healthcare and also improved patient safety and prevention of deaths. It could also enable patient-centered, comfort follow-up for patients treated by EVAR.

Interventions

The sensors are noninvasively attached

Sponsors

Tampere University of Technology
CollaboratorOTHER
Tampere University
CollaboratorOTHER
Tampere University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

* The patient has been clinically examined at policlinic of vascular surgery * The patient has been examined with computed tomography (CT) imaging * The patient has been considered a candidate for the EVAR of the AAA

Exclusion criteria

* A patient has a pacemaker * A medical doctor decides that the measurement disturbs or risks the subject's treatment process * Subject's denial (or withdrawal) * A patient has at least one amputated limb * The age of the test subject candidate is less than 18 years * A test subject candidate is not able to understand the study or is not legally competent * A test subject candidate has Ehlers-Danlos syndrome or Marfan syndrome

Design outcomes

Primary

MeasureTime frameDescription
Pulse wave change from baseline during EVAR measured by a force sensor2 hoursA force sensor node for dynamic pressure-PW measurements is utilized to detect pulse wave
Pulse wave change from baseline during EVAR measured by a optical photoplethysmographic (PPG) sensor2 hoursOptical photoplethysmographic (PPG) sensor node is used for volume pulse measurements

Secondary

MeasureTime frameDescription
Pulse wave change from baseline after EVAR measured by a force sensor30 daysA force sensor node for dynamic pressure-PW measurements is utilized to detect pulse wave
Pulse wave change from baseline after EVAR measured by a optical photoplethysmographic (PPG) sensor30 daysOptical photoplethysmographic (PPG) sensor node is used for volume pulse measurements
Pulse wave change from baseline after EVAR measured by a optical12 monthsOptical photoplethysmographic (PPG) sensor node is used for volume pulse measurements

Countries

Finland

Contacts

Primary ContactNiku Oksala, Professor
niku.oksala@professori.fi400591911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026