pCONus Treatment of Wide Neck Intracranial Aneurysms

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

Detailed Description
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Title: pCONus Treatment of Wide Neck Intracranial Aneurysms Acronym: pToWin Device: pCONus Bifurcation Aneurysm Implant Study design: Prospective, multicenter, single-arm clinical investigation Purpose: To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms Duration of the study: 48 months Sample size: 100 evaluable patients Number of sites: > 20 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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pToWin pCONus Treatment of Wide Neck Intracranial Aneurysms

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: implantation of the pCONus Bifurcation Aneurysm Implant


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 and ≤ 80 years. 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 pCONus 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
Maximum Age: 80 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: implantation of the pCONus Bifurcation Aneurysm Implant|The device will be introduced through a regular microcatheter. After deployment of the device with the crown positioned in the aneurysm neck the aneurysm will be entered with a microcatheter to perform endovascular coil occlusion. After completion of the coiling procedure the pCONus device will be electrolytically detached from the insertion wire and only the crown and the shaft will remain as a permanent implant.|

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) |  | Change from post-procedure to 3-6 and to 7-12 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 for each following point: To place pCONus in the desired location Correct opening of the device (crown and shaft) To perform aneurysm occlusion without obliteration of side branches and 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 for each following point: Vessel perforation Target aneurysm perforation with microcatheter or guidewire Target aneurysm perforation with pCONus Target aneurysm perforation with coils Thromboembolism 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 for each following point: Frequency of new parenchymal hemorrhage during the follow-up period Frequency of new subarachnoid hemorrhage during the follow-up period Frequency of new ischemic stroke on follow-up imaging Rupture of the target aneurysm during the 12 months follow-up period Rate of in-stent-stenosis 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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Aneurysm, bifurcation, wide neck, pCONus, intracerebral, stroke