Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04621552 |
| Other study ID # |
RECHMPL20_0601 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2015 |
| Est. completion date |
October 30, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
University Hospital, Montpellier |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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)
