Resumen

To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms.

Descripción detallada

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

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

Stenosis within the vascular access or target vessel ≥ 50 %.
Vessel tortuosity precluding safe access and device deployment.
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.
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.

Intervenciones

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.

pToWin pCONus Treatment of Wide Neck Intracranial Aneurysms