pCONus Treatment of Wide Neck Intracranial Aneurysms (pToWin)

pToWin pCONus Treatment of Wide Neck Intracranial Aneurysms

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

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: implantation of the pCONus Bifurcation Aneurysm Implant

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 Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autónoma De Buenos Aires
    • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, 1642
      • Clínica La Sagrada Familia Department of Neuroscience (P.L.), Equipo de Neurocirugía Endovascular y Radiología Intervencionista
• Austria
  • Graz, Austria, 8036
    • LKH-Univ. Klinikum Graz Universitätsklinik für Radiologie
• France
  • Bron cedex, France, 69500
    • Hôpital Pierre Wertheimer (HCL Groupement Hospitalier Est)
• Germany
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Koblenz, Germany, 56068
    • Gemeinschaftsklinikum Mittelrhein gGmbH
  • Osnabrück, Germany, 49076
    • Klinikum Osnabrück
  • Recklinghausen, Germany, 45657
    • Knappschaftskrankenhaus Recklinghausen
  • Stuttgart, Germany, 70174
    • Klinikum Stuttgart Katharinenhospital
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30167
      • KRH Klinikum Nordstadt
• Italy
  • Napoli, Italy, 80145
    • A.S.L. Napoli 1 Centro - P.O. San Giovanni Bosco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (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 pCONus 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 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Effectiveness	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	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" 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	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" 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	Change 1day post procedure up to 12months

Collaborators and Investigators

• Sponsor: Phenox GmbH
• Investigators: Principal Investigator: Alessandra Biondi, Prof. Dr., Hôpital Jean Minjoz (CHU Besançon), France

Publications and helpful links

General Publications

• Aguilar Perez M, Henkes H, Kurre W, Bleise C, Lylyk PN, Lundquist J, Turjman F, Alhazmi H, Loehr C, Felber S, Deutschmann H, Lowens S, Delehaye L, Mohlenbruch M, Hattingen J, Lylyk P. Results of the pToWin Study: Using the pCONUS Device for the Treatment of Wide-Neck Intracranial Aneurysms. J Clin Med. 2022 Feb 8;11(3):884. doi: 10.3390/jcm11030884.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: stroke; Aneurysm; bifurcation; wide neck; pCONus; intracerebral
• 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: PTW/PV201505-21

Drug and device information, study documents

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