Status:
UNKNOWN
pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2
Lead Sponsor:
Phenox GmbH
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18+ years
Brief Summary
To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation aneurysms.
Detailed Description
Title: pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2 Acronym: pToWin2 Device: pCONUS2 Bifurcation Aneurysm Implant Study design: Prospective, multicenter, single-arm clinical investigatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03273478
Start Date
December 1 2018
End Date
December 1 2021
Last Update
April 5 2018
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