Infrarenal Aortic AneurysmNCT01632631
Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance
An observational study of Infrarenal Aortic Aneurysm, run by University Hospital, Ghent at 3 sites in 2 countries.
Trial summary
Ongoing technological advances, especially in the field of image processing, have refined medical simulations to offer life-like replications of medical and surgical procedures in a variety of specialties. Patient-specific image data are incorporated into these simulations, and transformed into a 3D model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infrarenal Aortic Aneurysm
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2012to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an infrarenal aortic aneurysm suitable for endovascular exclusion. The suitability for endovascular repair is based upon the physician's decision.
Who may be able to join
- -infrarenal aortic aneurysm suitable for endovascular exclusion
Who cannot join
- Adult patients who do not have capacity to consent.
- Previous stent-graft implanted in the abdominal aorta
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites
Sint - Maarten Hospital, Campus Rooienberg
Duffel, 2570
Ghent University Hospital
Ghent, 9000
About this study
Official title: Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance. A Randomized Controlled Trial.
Ongoing technological advances, especially in the field of image processing, have refined medical simulations to offer life-like replications of medical and surgical procedures in a variety of specialties. Patient-specific image data are incorporated into these simulations, and transformed into a 3D model. This enables the practitioner and his/her team to perform and practice 'real' cases on a virtual patient prior to performing the real procedure on the actual patient. This new technology has been referred to as 'patient-specific' rehearsal, also 'mission' or 'procedure' rehearsal.
Research has already proven that simulated patient-specific rehearsal of a carotid artery stenting procedure may enhance surgical and team performance.
The PROcedure rehearsal software can now also be used to practice patient-specific endovascular repair of infrarenal aortic aneurysms (EVAR). The ability to rehearse a challenging and complex procedure like EVAR may not only influence device selection based on preoperative planning, but also improve the technical performance of the surgeon/radiologist and the awareness and communication within the entire endovascular team. However, further research is needed to evaluate if this new technology may enhance clinical safety and efficiency, i.e. if patients actually benefit from physicians and team members conducting patient-specific rehearsals of EVAR interventions.
- Conditions
- Infrarenal Aortic Aneurysm
- Keywords
- suitable for endovascular exclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PROcedure rehearsal | PROcedure rehearsal performed before real EVAR procedure No intervention | |
| No PROcedure rehearsal | no PROcedure rehearsal performed before real EVAR procedure No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical operative metrics
- C-arm positioning for proximal and distal landing zone
- Fluoroscopy time
- Number of angiograms
- Amount of contrast
Measured: during EVAR procedure
Errors occurring during EVAR procedure (Imperial College Error Capture record)
Measured: during EVAR procedure
Secondary outcomes (6)
Subjective sense of realism of patient-specific rehearsal reported by team members
Subjective sense of realism of patient-specific rehearsal reported by team members (Measurement: questionnaire)
Measured: immediately after EVAR procedure
Team satisfaction
Team satisfaction Measurement: questionnaire
Measured: immediately after EVAR procedure
Any deviation from initial treatment plan
Measured: immediately after EVAR procedure
30 day mortality and morbidity
Measured: within the first 30 days after surgery
Technical and clinical success rate
- Successful access to the arterial system using a remote site
- Successful deployment of the endoluminal graft with secure proximal and distal fixation
- Absence of either type I or III endoleak
- Patent endoluminal graft without significant twist, kinks, or obstruction
Measured: immediately after EVAR procedure
Initial clinical success
- Successful deployment of the endovascular device at the intended location, without:
- Death as a result of aneurysm-related treatment
- Type I or III endoleak
- Graft infection or thrombosis
- Aneurysm expansion (diameter > 5mm)
- Aneurysm rupture
- Conversion to open repair
- Graft dilatation (≥ 20% by diameter)
- Graft migration
- Failure of device integrity
Measured: within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infrarenal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liesbeth Desender, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632631
- Sponsor's protocol ID
- EC/2012/412
- Status last verified
- Dec 2022
- First submitted
- 28 Jun 2012
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Desender L, Van Herzeele I, Lachat M, Duchateau J, Bicknell C, Teijink J, Heyligers J, Vermassen F; PAVLOV Study Group. A Multicentre Trial of Patient specific Rehearsal Prior to EVAR: Impact on Procedural Planning and Team Performance. Eur J Vasc Endovasc Surg. 2017 Mar;53(3):354-361. doi: 10.1016/j.ejvs.2016.12.018. Epub 2017 Jan 20.
PubMed 28117241
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01632631
- Acronym / sponsor ID
- EC/2012/412
- Conditions
- Infrarenal Aortic Aneurysm
- Keywords
- suitable for endovascular exclusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 3 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ongoing technological advances, especially in the field of image processing, have refined medical simulations to offer life-like replications of medical and surgical procedures in a variety of specialties. Patient-specific image data are incorporated into these simulations, and transformed into a 3D model. This enables the practitioner and his/her team to perform and practice 'real' cases on a virtual patient prior to performing the real procedure on the actual patient. This new technology has been referred to as 'patient-specific' rehearsal, also 'mission' or 'procedure' rehearsal.
Research has already proven that simulated patient-specific rehearsal of a carotid artery stenting procedure may enhance surgical and team performance.
The PROcedure rehearsal software can now also be used to practice patient-specific endovascular repair of infrarenal aortic aneurysms (EVAR). The ability to rehearse a challenging and complex procedure like EVAR may not only influence device selection based on preoperative planning, but also improve the technical performance of the surgeon/radiologist and the awareness and communication within the entire endovascular team. However, further research is needed to evaluate if this new technology may enhance clinical safety and efficiency, i.e. if patients actually benefit from physicians and team members conducting patient-specific rehearsals of EVAR interventions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROcedure rehearsal | – | –PROcedure rehearsal performed before real EVAR procedure No intervention |
| No PROcedure rehearsal | – | –no PROcedure rehearsal performed before real EVAR procedure No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an infrarenal aortic aneurysm suitable for endovascular exclusion. The suitability for endovascular repair is based upon the physician's decision.
Key inclusion criteria (1 listed)
- -infrarenal aortic aneurysm suitable for endovascular exclusion
Key exclusion criteria (2 listed)
- Adult patients who do not have capacity to consent.
- Previous stent-graft implanted in the abdominal aorta
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical operative metrics
Time frame: during EVAR procedure
* C-arm positioning for proximal and distal landing zone * Fluoroscopy time * Number of angiograms * Amount of contrast
Errors occurring during EVAR procedure (Imperial College Error Capture record)
Time frame: during EVAR procedure
6 secondary outcomes
Subjective sense of realism of patient-specific rehearsal reported by team members
Time frame: immediately after EVAR procedure
Team satisfaction
Time frame: immediately after EVAR procedure
Any deviation from initial treatment plan
Time frame: immediately after EVAR procedure
30 day mortality and morbidity
Time frame: within the first 30 days after surgery
Technical and clinical success rate
Time frame: immediately after EVAR procedure
Initial clinical success
Time frame: within the first 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Derived from this study: PubMed 28117241Desender L, Van Herzeele I, Lachat M, Duchateau J, Bicknell C, Teijink J, Heyligers J, Vermassen F; PAVLOV Study Group. A Multicentre Trial of Patient specific Rehearsal Prior to EVAR: Impact on Procedural Planning and Team Performance. Eur J Vasc Endovasc Surg. 2017 Mar;53(3):354-361. doi: 10.1016/j.ejvs.2016.12.018. Epub 2017 Jan 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liesbeth Desender principal investigator
University Hospital, Ghent
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infrarenal Aortic Aneurysm, run by University Hospital, Ghent at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical operative metrics (time frame: during EVAR procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01632631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.