- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04621552
Virtual Simulation for Woven EndoBridge Device Sizing (VS-WEB)
Comparison of Woven EndoBridge Device Sizing With Conventional Measurements and Virtual Simulation Using the Sim&Size Software: A Multi-Center Experience
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Montpellier, France, 34295
- Uhmontpellier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Patients > 18 years treated with WEB for intracranial aneuryms
Exclusion criteria:
- Patients <18 years
- no eligibility for treatment with WEB
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median duration of the intervention
Time Frame: 1day
|
the median duration of the intervention
|
1day
|
Median radiation dose
Time Frame: 1 day
|
the median radiation dose
|
1 day
|
Need of corrective interventions
Time Frame: 1 day
|
the need of corrective interventions
|
1 day
|
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.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall rate of complications
Time Frame: 1 day
|
the overall rate of complications (peri-procedural and long-term adverse events)
|
1 day
|
morbidity rate
Time Frame: 1 day
|
the morbidity rate (complications associated with permanent change of the clinical and neurological status of the patient)
|
1 day
|
Rate of Aneurysm occlusion
Time Frame: 6 months and 12 months
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short-term (6 months) and long-term (12 months or more) aneurysm occlusion
|
6 months and 12 months
|
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).
|
6 months and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL20_0601
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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