Virtual Simulation for Woven EndoBridge Device Sizing (VS-WEB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04621552|
Recruitment Status : Completed
First Posted : November 9, 2020
Last Update Posted : November 10, 2020
|Condition or disease||Intervention/treatment|
|Aneurysm Intracranial Aneurysm||Device: WEB embolization|
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 :||Observational|
|Actual Enrollment :||186 participants|
|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|
- Device: WEB embolization
Treatment of intracranial aneurysms with WEB with the use of the virtual simulation before implantation of the device
- Median duration of the intervention [ Time Frame: 1day ]the median duration of the intervention
- Median radiation dose [ Time Frame: 1 day ]the median radiation dose
- Need of corrective interventions [ Time Frame: 1 day ]the need of corrective interventions
- 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.
- Overall rate of complications [ Time Frame: 1 day ]the overall rate of complications (peri-procedural and long-term adverse events)
- morbidity rate [ Time Frame: 1 day ]the morbidity rate (complications associated with permanent change of the clinical and neurological status of the patient)
- Rate of Aneurysm occlusion [ Time Frame: 6 months and 12 months ]short-term (6 months) and long-term (12 months or more) aneurysm occlusion
- 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
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
|Montpellier, France, 34295|
|Principal Investigator:||Federico Cagnazzo, MD PhD||UH Montpellier|