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In recent years, endovascular treatment of intracranial aneurysms has seen remarkable growth, now surpassing traditional surgical approaches in terms of frequency of use. However, this transition to endovascular methods is not without its challenges. This type of procedure requires careful selection of the device to be implanted, a decision that is still based on manual two-dimensional measurements. This method is questionable, as it does not always take into account the complexity and specificities of certain aneurysms, where three-dimensional geometry can play a crucial role. As a result, these procedures carry significant risks, such as the need for additional maneuvers to remove or reposition devices, or even deploy another support device, which potentially increases the risk of perioperative complications, the duration of surgery, and the amount of radiation required for imaging. Beyond the impact on the patient, these complications also result in additional costs for the healthcare system, expenses that could likely be avoided if more precise and appropriate tools were used from the outset of the procedure. In this context, optimizing the choice of endovascular devices could have both clinical and economic impacts. Innovative technology such as Sim&Size, which supports healthcare professionals in their therapeutic decisions and choice of the appropriate endovascular device, should therefore improve the effectiveness and efficiency of endovascular treatments.
Sim&Size is a Software as a Medical Device (SaMD) intended to provide a 3D view of the final placement of neurovascular implantable medical devices of the following types: flow diverters, intrasaccular devices, stent devices, and coils. It uses an actual image of the patient produced by 3D rotational angiography. It offers physicians the possibility of simulating the deployment of implantable medical devices in the artery to be treated and predicts the final placement and the extent of apposition of the implant. Sim&Size has CE marking and FDA clearance.
This study is a prospective, randomized, multicenter study whose main objective is to show that the use of Sim&Size during the standard endovascular procedure, compared with a standard endovascular procedure without Sim&Size, reduces both the actual costs of the hospital stay and the rate of perioperative complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual planning | Active Comparator | Investigator will use manual two-dimensional measurements to assess which neurovascular implantable medical device to use to treat the intracranial aneurysm. |
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| Sim&Size planning | Experimental | Investigator will use Sim&Size software, which allows for three dimensional representation of the aneurysm and for simulation of the placement of different types of devices, to support the choice of the neurovascular implantable medical device used to treat the intracranial aneurysm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D simulation of placement of neurovascular implantable medical device | Other | Using the Sim&Size software to obtain a 3D view of the final placement of neurovascular implantable medical devices of the following types: flow diverters, intrasaccular devices, stent devices, and coils, using an actual image of the patient produced by 3D rotational angiography. Used in the treatment of intracranial aneurysm. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Sim&Size use during endovascular procedure on healthcare costs | The main objective is to compare the use of Sim&Size during a standard endovascular procedure versus manual planning in modifying the healthcare costs of the hospital stay. This objective will be demonstrated through the use of the following criteria: -Difference in average direct hospital costs between the two groups. The two primary outcomes measures will be analyzed in a sequential hierarchical manner | From enrollment to the end of follow-up at 6 months |
| Impact of Sim&Size use during endovascular procedure on perioperative complications | The main objective is to compare the use of Sim&Size during a standard endovascular procedure versus manual planning in modifying the rate of perioperative complications. This objective will be demonstrated through the use of the following criteria: Difference in the rate of perioperative complications. The two primary outcomes measures will be analyzed in a sequential hierarchical manner | From enrollment to the end of follow-up at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate a change in average hospital costs by type of endovascular device used | Demonstrate a change in average healthcare costs by type of endovascular device used (flow diverter, coils or intra-saccular device) | From enrollment to end of follow-up at 6 months |
| Demonstrate a change in rate of perioperative complications by type of endovascular device used |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amandine RENE | Contact | +33783477287 | a.rene@sim-and-cure.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Recruiting | Angers | 49100 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33361275 | Background | Cagnazzo F, Marnat G, Ferreira I, Daube P, Derraz I, Dargazanli C, Lefevre PH, Gascou G, Riquelme C, Morganti R, Berge J, Gariel F, Barreau X, Costalat V. Comparison of Woven EndoBridge device sizing with conventional measurements and virtual simulation using the Sim&Size software: a multicenter experience. J Neurointerv Surg. 2021 Oct;13(10):924-929. doi: 10.1136/neurintsurg-2020-017060. Epub 2020 Dec 23. | |
| 32111727 |
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|
| Manual planning of endovascular procedure | Other | Manual planning of endovascular procedure using 2D images for placement of implantable medical devices for treatment of intracranial aneurysm. |
|
Demonstrate a change in rate of perioperative complications by type of endovascular device used |
| From surgery to the end of follow-up (6 months) |
| Change in the rate of aneurysm(s) recurrence | Demonstrate a change in the rate of aneurysm(s) recurrence at six months. Recurrence is defined as inadequate occlusion of the aneurysm on follow-up imaging at six months. | At 6 months post surgery |
| Change in operating time | Demonstrate a change in operating time during the endovascular procedure (in minutes) | From beginning to end of surgery (maximum of 24 hours) |
| Change of device deployment time | Demonstrate a change in the device deployment time during the endovascular procedure (in minutes) | From beginning to end of surgery (maximum of 24 hours) |
| Change in the number of endovascular devices used | Demonstrate a change in the number of implantable devices used during the endovascular procedure | From beginning to end of surgery (maximum of 24 hours) |
| Change in the number of wasted implantable devices | Demonstrate a change in the number of devices opened but not implanted or implanted but removed during the endovascular procedure. An opened device cannot be reused. | From beginning to end of surgery (maximum of 24 hours) |
| Change in the amount of imaging performed during the endovascular procedure | Change in the number of angiography and computed tomography imaging series performed during and immediately after deployment | From beginning to end of surgery (maximum of 24 hours) |
| Change in radiation exposure due to imaging | Demonstrate a change in radiation exposure (in mGy) | From beginning to end of surgery (maximum of 24 hours) |
| Change in duration of hospital stay | Demonstrate a modification of the duration of hospital stay (in days) from entering the hospital to exiting the hospital. | From entering the hospital to exiting the hospital (maximum of 1 month) |
| Change in the number of intensive care unit transfers/stays | Demonstrate a change in the number of intensive care unit transfers/stays after the surgery | From the surgery to the end of the follow-up at 6 months |
| Description of decreased healthcare costs linked to the use of Sim&Size | Qualitative and quantitative analysis of hospital resources saved through the use of Sim&Size | From enrollment to the end of follow-up at 6 months |
| Cost/consequence analysis of the use of Sim&Size | Carry out a cost/consequences analysis to compare the difference in costs observed in the main criterion with the multiple clinical consequences for the patient. | From enrollment to the end of follow-up at 6 months |
| CHU de Bordeaux | Recruiting | Bordeaux | 33000 | France |
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| Hôpital Bicêtre AP-HP | Recruiting | Le Kremlin-Bicêtre | 94270 | France |
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| Hôpital de La Timone | Not yet recruiting | Marseille | 13005 | France |
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| Fondation Rothschild | Not yet recruiting | Paris | 75019 | France |
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| CHU de Reims | Not yet recruiting | Reims | 51092 | France |
|
| Background |
| Piergallini L, Cagnazzo F, Conte G, Dargazanli C, Derraz I, Lefevre PH, Gascou G, Mantilla D, Riquelme C, Bonafe A, Costalat V. Virtual simulation with Sim&Size software for Pipeline Flex Embolization: evaluation of the technical and clinical impact. J Neurointerv Surg. 2020 Oct;12(10):968-973. doi: 10.1136/neurintsurg-2020-015813. Epub 2020 Feb 28. |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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