International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach

Study Overview
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Brief Summary
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IMPACT is an observational, post market study designed to provide an ongoing safety and performance evaluation of Stryker Neurovascular devices used for the treatment of intracranial aneurysms with an endovascular approach.

Detailed Description
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IMPACT is an international, prospective, observational, multicenter, non-randomized, post market study designed to provide ongoing safety and performance evaluation on implantable devices used for the treatment of intracranial aneurysms with an endovascular approach. Data collection will also include details on adjunctive and ancillary devices used. In addition, to gaining safety and performance data, this study will provide clinical evidence that may assist physicians in selecting an appropriate device(s) while describing treatment options used to treat patients with intracranial aneurysms.

Official Title
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IMPACT: International Post Market Product Surveillance Study of IntrACranial Aneurysms Treated With an Endovascular Approach

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: Endovascular treatment of intracranial aneurysms using a flow-diverting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Evolve EU and Evolve FR): Subject has an intracranial aneurysm that can be treated with one of the proposed devices Subject age is ≥ 18 years Subject or subject's legally authorized representative (LAR) has signed written informed consent Subject is willing to comply with scheduled visits and examinations per institutional standard of care Exclusion Criteria for (Evolve EU and Evolve FR): Subject is pregnant or plans to become pregnant her study participation*. Subject is currently enrolled in or plans to be enrolled in a concurrent drug or device study. Subject has a condition which will not allow him/her to comply with his/her post-procedure follow up per the institutional standard of care (medical condition, subject living abroad and unable to return for follow-up, e.g.). Subject has a non-target aneurysm treated within 30 days prior to study enrollment. Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study. Subject target aneurysm is a ruptured intracranial aneurysm (unless ruptured at least 21 days prior the day of the index procedure) Subject has a target aneurysm other than saccular or fusiform intracranial aneurysms; e.g.: vertebrobasilar dolichoectasia (VBD) The parent vessel size does not fall within the indicated range defined by IFU Antiplatelet and/or anticoagulation therapy (e.g., aspirin and clopidogrel) is contraindicated for the subject Subject has not received dual anti-platelet agents prior to the procedure or equivalent in accordance with standard medical practice Subject has an active bacterial or viral infection The angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as: Severe intracranial vessel tortuosity or stenosis; and/or Intracranial vasospasm not responsive to medical therapy Additional Key Exclusion Criteria (Evolve EU only): Subject has a non-target aneurysm treated within 30 days prior to study enrollment Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study Subject has a modified Rankin Score (mRS) ≥3 at pre-procedure examination Subject has undergone previous stent assisted coiling or flow diverter treatment of a parent artery aneurysm near the location of the target aneurysm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Evolve EU<br>Selected hospitals for participation | Device: Endovascular treatment of intracranial aneurysms using a flow-diverting stent<br>* The flow diverter brings about a reduction of blood flow to the aneurysm, which progresses over time into forming a stable thrombus within the aneurysm, as well as eventual aneurysm scarring and retraction. The flow diverter also acts as a scaffold for tissue growth across the neck of the aneurysm, which blocks the aneurysm from the artery blood flow.<br>|
| Evolve FR<br>All hospitals in France using the device | Device: Endovascular treatment of intracranial aneurysms using a flow-diverting stent<br>* The flow diverter brings about a reduction of blood flow to the aneurysm, which progresses over time into forming a stable thrombus within the aneurysm, as well as eventual aneurysm scarring and retraction. The flow diverter also acts as a scaffold for tissue growth across the neck of the aneurysm, which blocks the aneurysm from the artery blood flow.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Performance Measure | Composite of 100% occlusion of the target aneurysm without significant parent artery stenosis per independent core lab assessment and with no target aneurysm retreatment | 12 months | 
| Primary Safety Endpoint | Stroke-related neurological death or Disabling stroke in the target vessel territory as adjudicated by an independent Clinical Events Committee (CEC) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Performance Measures | Target aneurysm recanalization, Parent artery stenosis ≥ 50%, Target aneurysm retreatment, Target aneurysm occlusion status, Aneurysm size evaluation | Through 24 months | 
| Secondary Safety Endpoints | Procedural and device related serious adverse events, Any key neurological event of interest | Through 24 months |