pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2

Study Overview
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Brief Summary
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To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation aneurysms.

Detailed Description
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Title: pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2 Acronym: pToWin2 Device: pCONUS2 Bifurcation Aneurysm Implant Study design: Prospective, multicenter, single-arm clinical investigation Purpose: To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation aneurysms Duration of the study: 30 months Sample size: 100 evaluable patients Number of sites: max. 15 Follow-up intervals: Two independent follow-ups (after 3-6 and 7-12 months) according to site specific standard

Official Title
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pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: Endovascular treatment of bifurcation aneurysm with pCONUS2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aneurysm status: Unruptured aneurysm or Ruptured aneurysm with a Hunt and Hess grade of I - III. Age ≥18. The patient or legal representative provides written informed consent. The patient shows general compliance to follow the medical regimen and to attend follow-up examinations. The target aneurysm is located at one of the following cerebral vessel bifurcations: ICA terminus, AcomA, MCA or BA. Bifurcation wide neck aneurysm. The dome height should allow for safe deployment of the device crown. The fundus of the aneurysm should offer enough space for the crown of the pCONUS2 to deploy. Exclusion Criteria: Vessel tortuosity precluding safe access and device deployment. Stenosis within the vascular access or target vessel ≥ 50 %. The target aneurysm has been previously treated with a stent or an intraaneurysmal implant beside coils. The treatment plan for the target aneurysm includes the use of additional intra- and/or extraaneurysmal temporary or permanent implants other than coils. More than one intracerebral aneurysm requires the treatment within the following 6 months. Imaging evidence of an arteriovenous cerebrovascular malformation or a dural fistula. Any physical, medical or psychiatric condition of the patient interfering with the adherence of the requirements and follow-up regimen of the study. Any neurological disorder with progressive neurological symptoms, except attributable to a compressive effect of the target aneurysm. Current involvement in another study or trial. Women of child bearing potential or breast-feeding who cannot provide a negative pregnancy test. Known allergy to the components of device, study medication or contrast media that cannot be controlled medically. A medical condition interfering with a dual antiplatelet treatment. Known coagulopathy. Intracranial hemorrhage in the past 30 days apart from the target aneurysm. Ischemic stroke in the past 30 days. Myocardial infarction in the past 30 days. Major surgery in the past 30 days. Evidence of active infection at time of treatment. Co -morbidities or conditions with a life expectancy less than 12 months. Additional Exclusion criteria for ruptured aneurysm at the acute phase: The patient is clinically severely affected (Hunt and Hess grade IV and V). Severe vasospasm is proven during angiography. Proven parenchymal hemorrhage by CT or MRI. Proven subdural hematoma by CT or MRI.

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

| Intervention/Treatment |
| --- |
|Device: Endovascular treatment of bifurcation aneurysm with pCONUS2|Patients suffering from a bifurcation aneurysm will be treated endovascularly with the pCONUS2 device. The patients do not face any additional risks by participating in the study as the treatment does not differ from the standard of care in any way. The patients will only be enrolled in the study if they give their written consent. If they do not wish to participate in the observational study or if they wish to withdraw from it at a later date, they will not have any disadvantages.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness: Aneurysm occlusion (complete or neck remnant) | Assessment by Raymond-Roy occlusion scale | Change from post-procedure to 12 months | 
| Safety: Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm |  | within 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness: The Effectiveness endpoint is assessed throughout the intervention and is assessed as number/amount of: | - To place pCONUS2 in the desired location | at the time of the procedure | 
| Effectiveness: The Effectiveness endpoint is assessed throughout the intervention and is assessed as number/amount of: | - Correct opening of the device (crown and shaft) | at the time of the procedure | 
| Effectiveness: The Effectiveness endpoint is assessed throughout the intervention and is assessed as number/amount of: | - To perform aneurysm occlusion without obliteration of side branches | at the time of the procedure | 
| Effectiveness: The Effectiveness endpoint is assessed throughout the intervention and is assessed as number/amount of: | - To detach the device at the end of the procedure | at the time of the procedure | 
| Safety Intra-Procedural Complications The Safety Intra-Procedural Complications endpoint is assessed throughout the intervention and is assessed as number/amount of: | - Vessel perforation | at the time of the procedure | 
| Safety Intra-Procedural Complications The Safety Intra-Procedural Complications endpoint is assessed throughout the intervention and is assessed as number/amount of: | - Target aneurysm perforation with microcatheter or guidewire | at the time of the procedure | 
| Safety Intra-Procedural Complications The Safety Intra-Procedural Complications endpoint is assessed throughout the intervention and is assessed as number/amount of: | - Target aneurysm perforation with pCONUS2 | at the time of the procedure | 
| Safety Intra-Procedural Complications The Safety Intra-Procedural Complications endpoint is assessed throughout the intervention and is assessed as number/amount of: | - Target aneurysm perforation with coils | at the time of the procedure | 
| Safety Intra-Procedural Complications The Safety Intra-Procedural Complications endpoint is assessed throughout the intervention and is assessed as number/amount of: | - Thromboembolism | at the time of the procedure | 
| Safety Intra-Procedural Complications The Safety Intra-Procedural Complications endpoint is assessed throughout the intervention and is assessed as number/amount of: | - Dissection of any access vessel | at the time of the procedure | 
| Safety Post-Procedural Complications The Safety Post-Procedural Complications endpoint is assessed throughout the intervention and is assessed as number/amount of: | - Frequency of new parenchymal hemorrhage | Change 1day post procedure up to 12months | 
| Safety Post-Procedural Complications The Safety Post-Procedural Complications endpoint is assessed throughout the intervention and is assessed as number/amount of: | - Frequency of new subarachnoid hemorrhage | Change 1day post procedure up to 12months | 
| Safety Post-Procedural Complications The Safety Post-Procedural Complications endpoint is assessed throughout the intervention and is assessed as number/amount of: | - Frequency of new ischemic stroke | Change 1day post procedure up to 12months | 
| Safety Post-Procedural Complications The Safety Post-Procedural Complications endpoint is assessed throughout the intervention and is assessed as number/amount of: | - Rupture of the target aneurysm | Change 1day post procedure up to 12months | 
| Safety Post-Procedural Complications The Safety Post-Procedural Complications endpoint is assessed throughout the intervention and is assessed as number/amount of: | - Rate of in-stent-stenosis | Change 1day post procedure up to 12months | 
| Safety Post-Procedural Complications The Safety Post-Procedural Complications endpoint is assessed throughout the intervention and is assessed as number/amount of: | - Rate of in-stent-thrombosis | Change 1day post procedure up to 12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bifurcation aneurysm, Unruptured bifurcation aneurysm, Ruptured bifurcation aneurysm, Stent-assisted coiling, pCONUS2 Bifurcation Aneurysm Implant