pCONus Treatment of Wide Neck Intracranial Aneurysms

Launched by PHENOX GMBH · Sep 17, 2015

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Aneurysm status:
• • Unruptured aneurysm or
• • Ruptured aneurysm with a Hunt and Hess grade of I - III.
• • 2. Age ≥18 and ≤ 80 years.
• • 3. The patient or legal representative provides written informed consent.
• • 4. The patient shows general compliance to follow the medical regimen and to attend follow-up examinations.
• • 5. The target aneurysm is located at one of the following cerebral vessel bifurcations: ICA terminus, AcomA, MCA or BA.
• • 6. Bifurcation wide neck aneurysm.
• • 7. 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:
• • 1. Vessel tortuosity precluding safe access and device deployment.
• • 2. Stenosis within the vascular access or target vessel ≥ 50 %.
• • 3. The target aneurysm has been previously treated with a stent or an intraaneurysmal implant beside coils.
• • 4. The treatment plan for the target aneurysm includes the use of additional intra- and/or extraaneurysmal temporary or permanent implants other than coils.
• • 5. More than one intracerebral aneurysm requires the treatment within the following 6 months.
• • 6. Imaging evidence of an arteriovenous cerebrovascular malformation or a dural fistula.
• • 7. Any physical, medical or psychiatric condition of the patient interfering with the adherence of the requirements and follow-up regimen of the study.
• • 8. Any neurological disorder with progressive neurological symptoms, except attributable to a compressive effect of the target aneurysm.
• • 9. Current involvement in another study or trial.
• • 10. Women of child bearing potential or breast-feeding who cannot provide a negative pregnancy test.
• • 11. Known allergy to the components of device, study medication or contrast media that cannot be controlled medically.
• • 12. A medical condition interfering with a dual antiplatelet treatment.
• • 13. Known coagulopathy.
• • 14. Intracranial hemorrhage in the past 30 days apart from the target aneurysm.
• • 15. Ischemic stroke in the past 30 days.
• • 16. Myocardial infarction in the past 30 days.
• • 17. Major surgery in the past 30 days.
• • 18. Evidence of active infection at time of treatment.
• • 19. Co -morbidities or conditions with a life expectancy less than 12 months.
• 20. Additional Exclusion criteria for ruptured aneurysm at the acute phase:
• • 1. The patient is clinically severely affected (Hunt and Hess grade IV and V).
• • 2. Severe vasospasm is proven during angiography.
• • 3. Proven parenchymal hemorrhage by CT or MRI.
• • 4. Proven subdural hematoma by CT or MRI.