NCT01632631

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 3, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

1.7 years

First QC Date

June 28, 2012

Last Update Submit

December 13, 2022

Conditions

Infrarenal Aortic Aneurysm

Keywords

suitable for endovascular exclusion

Outcome Measures

Primary Outcomes (2)

  • Technical operative metrics

    * C-arm positioning for proximal and distal landing zone * Fluoroscopy time * Number of angiograms * Amount of contrast

    during EVAR procedure

  • Errors occurring during EVAR procedure (Imperial College Error Capture record)

    during EVAR procedure

Secondary Outcomes (6)

  • Subjective sense of realism of patient-specific rehearsal reported by team members

    immediately after EVAR procedure

  • Team satisfaction

    immediately after EVAR procedure

  • Any deviation from initial treatment plan

    immediately after EVAR procedure

  • 30 day mortality and morbidity

    within the first 30 days after surgery

  • Technical and clinical success rate

    immediately after EVAR procedure

  • +1 more secondary outcomes

Study Arms (2)

PROcedure rehearsal

PROcedure rehearsal performed before real EVAR procedure No intervention

No PROcedure rehearsal

no PROcedure rehearsal performed before real EVAR procedure No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with an infrarenal aortic aneurysm suitable for endovascular exclusion. The suitability for endovascular repair is based upon the physician's decision.

You may not qualify if:

  • Adult patients who do not have capacity to consent.
  • Previous stent-graft implanted in the abdominal aorta

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sint - Maarten Hospital, Campus Rooienberg

Duffel, 2570, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

Zurich University Hospital

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 28117241DERIVED

Study Officials

  • Liesbeth Desender

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2012

First Posted

July 3, 2012

Study Start

September 1, 2012

Primary Completion

June 1, 2014

Study Completion

August 1, 2016

Last Updated

December 14, 2022

Record last verified: 2022-12

Locations

BE(2)CH(1)