CompletedNot Applicable

pCONus Treatment of Wide Neck Intracranial Aneurysms

Argentina, Austria, France116 participantsStarted 2015-08

Plain-language summary

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

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Aneurysm status:
✓. 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.

✕. 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.

Effectiveness Aneurysm occlusion (complete or neck remnant)

Timeframe: 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

Timeframe: within 12 months

NCT IDNCT02554708

SponsorPhenox GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-10

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Aneurysm status:
✓. 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.

✕. 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.