pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2

• Conditions: Intracranial Aneurysm

• Registration Number: NCT03273478
• Lead Sponsor: Phenox GmbH

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 investigation

Purpose: To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation aneurysms

Duration of the study: 30 months

Sample size: 100 evaluable patients

Number of sites: max. 15

Follow-up intervals: Two independent follow-ups (after 3-6 and 7-12 months) according to site specific standard

Study Timeline

• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-06
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-05
• Study Start: 2018-12
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Aneurysm status:

   • Unruptured aneurysm or
   • Ruptured aneurysm with a Hunt and Hess grade of I - III.

2. Age ≥18.

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 pCONUS2 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm	within 12 months
Effectiveness: Aneurysm occlusion (complete or neck remnant)	Change from post-procedure to 12 months	Assessment by Raymond-Roy occlusion scale

Secondary Outcome Measures

Name	Time	Method
Safety Intra-Procedural Complications The "Safety Intra-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":	at the time of the procedure	- Dissection of any access vessel
Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":	at the time of the procedure	- To detach the device at the end of the procedure
Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":	Change 1day post procedure up to 12months	- Rate of in-stent-thrombosis