pCONus Treatment of Wide Neck Intracranial Aneurysms

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2022
• Main ID: NCT02554708
• Date of registration: 04/09/2015
• Prospective Registration: No
• Primary sponsor: Phenox GmbH
• Public title: pCONus Treatment of Wide Neck Intracranial Aneurysms pToWin
• Scientific title: pToWin pCONus Treatment of Wide Neck Intracranial Aneurysms
• Date of first enrolment: August 2015
• Target sample size: 116
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02554708
• Study type: Observational

Countries of recruitment

Argentina, Austria, Belgium, France, Germany, Italy, United Kingdom

Contacts

• Name: Alessandra Biondi, Prof. Dr.
• Affiliation: Hôpital Jean Minjoz (CHU Besançon), France

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Intracranial Aneurysm

Intervention(s)

Device: implantation of the pCONus Bifurcation Aneurysm Implant

Primary Outcome(s)

Effectiveness Aneurysm occlusion (complete or neck remnant) [Time Frame: 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 [Time Frame: within 12 months]

Secondary Outcome(s)

Effectiveness [Time Frame: at the time of the procedure]

Safety Intra-Procedural Complications [Time Frame: at the time of the procedure]

Safety Post-Procedural Complications [Time Frame: Change 1day post procedure up to 12months]

Secondary ID(s)

PTW/PV201505-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors