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

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Abdominal aortic aneurysm
Related Access Program
Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

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

Official Title

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

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.

Study Type

Observational

Primary Outcome

Pulse wave change from baseline during EVAR measured by a force sensor

Secondary Outcome

 Pulse wave change from baseline after EVAR measured by a force sensor

Condition

Cardiovascular Diseases

Intervention

Noninvasive pulse wave analysis sensor, ECG-sensor

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

30

Start Date

April 8, 2018

Completion Date

August 30, 2021

Primary Completion Date

August 30, 2021

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 120 Years

Accepts Healthy Volunteers

No

Contacts

, 400591911, [email protected]

Location Countries

Finland

Location Countries

Finland

Administrative Informations

NCT ID

NCT03493074

Organization ID

R17129

Responsible Party

Sponsor

Study Sponsor

Tampere University Hospital

Collaborators

 Tampere University of Technology

Study Sponsor

, ,

Verification Date

October 2020