pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2 (pToWin2)

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

Study Overview

• Status: Unknown
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Endovascular treatment of bifurcation aneurysm with pCONUS2

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Konopka; Phone Number: +49 0234 36919; Email: pToWin2@phenox.info
• Study Contact Backup: Name: Treffner, Dr.; Phone Number: +49 0234 36919; Email: pToWin2@phenox.info

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients harbouring an unruptured or ruptured bifurcation aneurysm, in which pCONUS2-assisted coiling was judged to be the most appropriate treatment

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness: Aneurysm occlusion (complete or neck remnant)	Assessment by Raymond-Roy occlusion scale	Change from post-procedure to 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

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Phenox GmbH

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Bifurcation aneurysm; Unruptured bifurcation aneurysm; Ruptured bifurcation aneurysm; Stent-assisted coiling; pCONUS2 Bifurcation Aneurysm Implant
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: PTW2/PH/20170823

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No