Non-invasive Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm (VBA)
VBA
Non-invasive Peri- and Postoperative Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm
1 other identifier
observational
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2018
CompletedStudy Start
First participant enrolled
April 8, 2018
CompletedFirst Posted
Study publicly available on registry
April 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2021
CompletedOctober 9, 2020
October 1, 2020
3.4 years
March 20, 2018
October 8, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Pulse wave change from baseline during EVAR measured by a force sensor
A force sensor node for dynamic pressure-PW measurements is utilized to detect pulse wave
2 hours
Pulse wave change from baseline during EVAR measured by a optical photoplethysmographic (PPG) sensor
Optical photoplethysmographic (PPG) sensor node is used for volume pulse measurements
2 hours
Secondary Outcomes (4)
Pulse wave change from baseline after EVAR measured by a force sensor
30 days
Pulse wave change from baseline after EVAR measured by a optical photoplethysmographic (PPG) sensor
30 days
Pulse wave change from baseline after EVAR measured by a force sensor
12 months
Pulse wave change from baseline after EVAR measured by a optical
12 months
Interventions
The sensors are noninvasively attached
Eligibility Criteria
Finnish, Caucasian
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tampere University Hospitallead
- Tampere University of Technologycollaborator
- Tampere Universitycollaborator
Study Sites (1)
Tampere University Hospital
Tampere, FI-33014, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2018
First Posted
April 10, 2018
Study Start
April 8, 2018
Primary Completion
August 30, 2021
Study Completion
August 30, 2021
Last Updated
October 9, 2020
Record last verified: 2020-10