Assessment of the Clinical and Economic Impact of Sim&Size, a Simulation Software for Implantable Devices Used in the Treatment of Intracranial Aneurysms: A Prospective Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 576
- 试验地点
- 6
- 主要终点
- Impact of Sim&Size use during endovascular procedure on healthcare costs
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years planned to be treated endovascularly for unruptured intracranial aneurysms.
- •Planned implantable device models is available in the Sim&Size simulation database and used following their approved indications.
- •Affiliated with the French social security system.
- •Signed the information and consent form
排除标准
- •Patients scheduled to undergo endovascular treatment with stents only
- •Patients presenting for treatment of a ruptured aneurysm
- •Patients who have already been treated in the planned deployment area and whose previous treatment presents a potential contact with the new implant.
- •Giant intracranial aneurysm resulting in poor-quality reconstruction in the potential deployment area of the implant during 3DRA acquisition
- •Presence of artifacts on the 3DRA in the potential deployment area of the implant
- •Patients with multiple aneurysms whose treatment is planned during a single procedure and who require separate individual therapeutic strategies. Examples of individual therapeutic strategies excluded from the study: placement of two separate flow diverters without telescopic technique, individual coiling of each aneurysm.
- •Patients for whom pre-planning was performed using Sim&Cure software prior to patient randomization.
- •Pregnant or breastfeeding women.
- •Patients under guardianship or conservatorship.
- •Emergency situations.
研究组 & 干预措施
Manual planning
Investigator will use manual two-dimensional measurements to assess which neurovascular implantable medical device to use to treat the intracranial aneurysm.
干预措施: Manual planning of endovascular procedure (Other)
Sim&Size planning
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.
干预措施: 3D simulation of placement of neurovascular implantable medical device (Other)
结局指标
主要结局
Impact of Sim&Size use during endovascular procedure on healthcare costs
时间窗: From enrollment to the end of follow-up at 6 months
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
Impact of Sim&Size use during endovascular procedure on perioperative complications
时间窗: From enrollment to the end of follow-up at 6 months
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
次要结局
- Demonstrate a change in average hospital costs by type of endovascular device used(From enrollment to end of follow-up at 6 months)
- 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(At 6 months post surgery)
- Change in operating time(From beginning to end of surgery (maximum of 24 hours))
- Change of device deployment time(From beginning to end of surgery (maximum of 24 hours))
- Change in the number of endovascular devices used(From beginning to end of surgery (maximum of 24 hours))
- Change in the number of wasted implantable devices(From beginning to end of surgery (maximum of 24 hours))
- Change in the amount of imaging performed during the endovascular procedure(From beginning to end of surgery (maximum of 24 hours))
- Change in radiation exposure due to imaging(From beginning to end of surgery (maximum of 24 hours))
- Change in duration of hospital stay(From entering the hospital to exiting the hospital (maximum of 1 month))
- Change in the number of intensive care unit transfers/stays(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(From enrollment to the end of follow-up at 6 months)
- Cost/consequence analysis of the use of Sim&Size(From enrollment to the end of follow-up at 6 months)