pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-31

Study Completion Date

2021-12-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Intracranial Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Endovascular treatment of bifurcation aneurysm with pCONUS2

Patients suffering from a bifurcation aneurysm will be treated endovascularly with the pCONUS2 device.

* The patients do not face any additional risks by participating in the study as the treatment does not differ from the standard of care in any way.
* The patients will only be enrolled in the study if they give their written consent.
* If they do not wish to participate in the observational study or if they wish to withdraw from it at a later date, they will not have any disadvantages.

Intervention Type DEVICE

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No