pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2

Intracranial Aneurysm Clinical Trial

— pToWin2  

Official title:

pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03273478
• Other study ID #: PTW2/PH/20170823
• Status: Not yet recruiting
• First received: August 23, 2017
• Last updated: April 4, 2018
• Start date: December 2018
• Est. completion date: December 2021

Study information

• Verified date: April 2018
• Source: Phenox GmbH
• Contact: Konopka
• Phone: +49 0234 36919
• Email: pToWin2[@]phenox.info
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Phenox GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness: Aneurysm occlusion (complete or neck remnant)	Assessment by Raymond-Roy occlusion scale	Change from post-procedure to 12 months
Primary	Safety: Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm		within 12 months
Secondary	Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":	- To place pCONUS2 in the desired location	at the time of the procedure
Secondary	Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":	- Correct opening of the device (crown and shaft)	at the time of the procedure
Secondary	Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":	- To perform aneurysm occlusion without obliteration of side branches	at the time of the procedure
Secondary	Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":	- To detach the device at the end of the procedure	at the time of the procedure
Secondary	Safety Intra-Procedural Complications The "Safety Intra-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":	- Vessel perforation	at the time of the procedure
Secondary	Safety Intra-Procedural Complications The "Safety Intra-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":	- Target aneurysm perforation with microcatheter or guidewire	at the time of the procedure
Secondary	Safety Intra-Procedural Complications The "Safety Intra-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":	- Target aneurysm perforation with pCONUS2	at the time of the procedure
Secondary	Safety Intra-Procedural Complications The "Safety Intra-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":	- Target aneurysm perforation with coils	at the time of the procedure
Secondary	Safety Intra-Procedural Complications The "Safety Intra-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":	- Thromboembolism	at the time of the procedure
Secondary	Safety Intra-Procedural Complications The "Safety Intra-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":	- Dissection of any access vessel	at the time of the procedure
Secondary	Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":	- Frequency of new parenchymal hemorrhage	Change 1day post procedure up to 12months
Secondary	Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":	- Frequency of new subarachnoid hemorrhage	Change 1day post procedure up to 12months
Secondary	Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":	- Frequency of new ischemic stroke	Change 1day post procedure up to 12months
Secondary	Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":	- Rupture of the target aneurysm	Change 1day post procedure up to 12months
Secondary	Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":	- Rate of in-stent-stenosis	Change 1day post procedure up to 12months
Secondary	Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":	- Rate of in-stent-thrombosis	Change 1day post procedure up to 12months