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Virtual Simulation for Woven EndoBridge Device Sizing (VS-WEB)

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ClinicalTrials.gov Identifier: NCT04621552
Recruitment Status : Completed
First Posted : November 9, 2020
Last Update Posted : November 10, 2020
Sponsor:
Collaborator:
University Hospital, Bordeaux
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:
Selection of the appropriate size of the device is mandatory during aneurysm treatment with a WEB. The Investigators aimed to investigate if virtual simulation with Sim&Size software may have an impact on technical, angiographic, and clinical outcomes after WEB treatment. Data from two large-volume centers were collected and compared (January 2017-January 2020). Virtual simulation was systematically adopted in one center, while conventional sizing was used in the other one. Outcomes were the duration of intervention, the radiation dose (mGy), the number of corrective interventions for inappropriate WEB size, the number of WEBs not deployed, angiographic occlusion, and complications. Univariate and multivariate linear models were adopted.

Condition or disease Intervention/treatment
Aneurysm Intracranial Aneurysm Device: WEB embolization

Detailed Description:

Flow disruption with Woven EndoBridge (WEB) is an innovative treatment that has been evaluated in several prospective and retrospective studies1-3. The efficacy and safety of this strategy has been largely proved, and nowadays, indications for WEBs are progressively enlarged. Appropriate sizing of the device is the key factor for treatment with a WEB. Undersized devices may lead to insufficient coverage of the aneurysm neck and inadequate filling of the volume of the sac, lowering the angiographic success. On the other hand, an excessively oversized WEB may cause an unwarranted protrusion into the parent vessel, increasing the risk of ischemic events. The conventional approach for WEB sizing is based on two-dimensional digital subtraction angiography (2D-DSA), adding 1mm to the average width (to assure good wall apposition), and subtracting 1mm to the average height of the aneurysm (to adjust for the longitudinal increase caused by the horizontal compression)4. However, the operator has to anticipate the behavior of the device, predicting tridimensional modifications of the WEB in relation to the volume and shape of the aneurysm dome and neck. Accordingly, appropriate WEB sizing could be difficult and may require experience. Data about software-based simulation to predict changes after device implantation have been reported for flow diversion and braided stents5-7. The Sim&Size software (Sim&Cure, Grabels, France) is able to perform virtual sizing before WEB deployment using pre or per-operative three-dimensional rotational angiography (3D-RA) acquisition. The virtual simulation helps to select the most appropriate size of the device, predicting the behavior of the WEB inside the aneurysm dome, and the surface of the WEB apposition, anticipating protrusion over the neck or inappropriate coverage of the ostium. This multicenter study aimed to explore if the use of the Sim&Size software during endovascular embolization of intracranial aneurysms with WEB devices was associated with measurables procedural advantages compared with conventional sizing methods.

The primary investigated outcomes were 1) the median duration of the intervention; 2) the median radiation dose; 3) the need of corrective interventions; and 4) the number of WEBs opened but finally not deployed because of the inappropriate size of the device.

The secondary investigated endpoints were 1) the overall rate of complications (peri-procedural and long-term adverse events); 2) the morbidity rate (complications associated with permanent change of the clinical and neurological status of the patient); and 3) short-term (6 months) and long-term (12 months or more) aneurysm occlusion and WEB-shape change ("compaction") (decrease in height of the device or a deepening of the proximal and distal concave recesses during follow-up9 based on non-subtracted images)

Study Design
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Study Type : Observational
Actual Enrollment : 186 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Comparison of Woven EndoBridge Device Sizing With Conventional Measurements and Virtual Simulation Using the Sim&Size Software: A Multi-Center Experience
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: WEB embolization
    Treatment of intracranial aneurysms with WEB with the use of the virtual simulation before implantation of the device

Outcome Measures
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Primary Outcome Measures :
  1. Median duration of the intervention [ Time Frame: 1day ]
    the median duration of the intervention

  2. Median radiation dose [ Time Frame: 1 day ]
    the median radiation dose

  3. Need of corrective interventions [ Time Frame: 1 day ]
    the need of corrective interventions

  4. number of WEBs opened [ Time Frame: 1 day ]
    the number of WEBs opened but finally not deployed because of the inappropriate size of the device.


Secondary Outcome Measures :
  1. Overall rate of complications [ Time Frame: 1 day ]
    the overall rate of complications (peri-procedural and long-term adverse events)

  2. morbidity rate [ Time Frame: 1 day ]
    the morbidity rate (complications associated with permanent change of the clinical and neurological status of the patient)

  3. Rate of Aneurysm occlusion [ Time Frame: 6 months and 12 months ]
    short-term (6 months) and long-term (12 months or more) aneurysm occlusion

  4. WEB-shape change [ Time Frame: 6 months and 12 months ]
    WEB-shape change ("compaction") (decrease in height of the device or a deepening of the proximal and distal concave recesses during follow-up9 based on non-subtracted images).


Biospecimen Retention:   None Retained
NC

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients >18 years treated with WEB for an intracranial aneurysms
Criteria

Inclusion criteria:

- Patients > 18 years treated with WEB for intracranial aneuryms

Exclusion criteria:

  • Patients <18 years
  • no eligibility for treatment with WEB
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621552


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
University Hospital, Bordeaux
Investigators
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Principal Investigator: Federico Cagnazzo, MD PhD UH Montpellier
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04621552    
Other Study ID Numbers: RECHMPL20_0601
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Intracranial Aneurysm
WEB
virtual simuation
SARS-CoV-2
Unruptured and Ruptrued intracranial aneurysms
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases