pCONus Treatment of Wide Neck Intracranial Aneurysms

Completed

• Conditions: Intracranial Aneurysm

• Registration Number: NCT02554708
• Lead Sponsor: Phenox GmbH

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness Aneurysm occlusion (complete or neck remnant)	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	within 12 months

Secondary Outcome Measures

Name	Time	Method
Safety Intra-Procedural Complications	at the time of the procedure	The "Safety Intra-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of" for each following point: * Vessel perforation; * Target aneurysm perforation with microcatheter or guidewire; * Target aneurysm perforation with pCONus; * Target aneurysm perforation with coils; * Thromboembolism; * Dissection of any access vessel
Safety Post-Procedural Complications	Change 1day post procedure up to 12months	The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of" for each following point: * Frequency of new parenchymal hemorrhage during the follow-up period; * Frequency of new subarachnoid hemorrhage during the follow-up period; * Frequency of new ischemic stroke on follow-up imaging; * Rupture of the target aneurysm during the 12 months follow-up period; * Rate of in-stent-stenosis; * Rate of in-stent-thrombosis
Effectiveness	at the time of the procedure	The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of" for each following point: * To place pCONus in the desired location; * Correct opening of the device (crown and shaft); * To perform aneurysm occlusion without obliteration of side branches and; * To detach the device at the end of the procedure

Trial Locations

Locations (10)

Klinikum Stuttgart Katharinenhospital; 🇩🇪 Stuttgart, Germany

LKH-Univ. Klinikum Graz Universitätsklinik für Radiologie; 🇦🇹 Graz, Austria

Hôpital Pierre Wertheimer (HCL Groupement Hospitalier Est); 🇫🇷 Bron cedex, France

KRH Klinikum Nordstadt; 🇩🇪 Hannover, Niedersachsen, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Gemeinschaftsklinikum Mittelrhein gGmbH; 🇩🇪 Koblenz, Germany

Klinikum Osnabrück; 🇩🇪 Osnabrück, Germany

Knappschaftskrankenhaus Recklinghausen; 🇩🇪 Recklinghausen, Germany

A.S.L. Napoli 1 Centro - P.O. San Giovanni Bosco; 🇮🇹 Napoli, Italy

Clínica La Sagrada Familia Department of Neuroscience (P.L.), Equipo de Neurocirugía Endovascular y Radiología Intervencionista; 🇦🇷 Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina