pCONus Treatment of Wide Neck Intracranial Aneurysms

NCT02554708 | Completed DMC

• 1 other identifier: PTW/PV201505-21
• Study Type: observational
• Target: 116
• Locations: 5 countries
• Sites: 10

Brief Summary

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

Conditions

Intracranial Aneurysm

Keywords

Aneurysm; bifurcation; wide neck; pCONus; intracerebral; stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Effectiveness

  at the time of the procedure

• Safety Intra-Procedural Complications

  at the time of the procedure

• Safety Post-Procedural Complications

  Change 1day post procedure up to 12months

Interventions

implantation of the pCONus Bifurcation Aneurysm Implant DEVICE

The device will be introduced through a regular microcatheter. After deployment of the device with the crown positioned in the aneurysm neck the aneurysm will be entered with a microcatheter to perform endovascular coil occlusion. After completion of the coiling procedure the pCONus device will be electrolytically detached from the insertion wire and only the crown and the shaft will remain as a permanent implant.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Aneurysm status:
• Unruptured aneurysm or
• Ruptured aneurysm with a Hunt and Hess grade of I - III.
• Age ≥18 and ≤ 80 years.
• The patient or legal representative provides written informed consent.
• The patient shows general compliance to follow the medical regimen and to attend follow-up examinations.
• The target aneurysm is located at one of the following cerebral vessel bifurcations: ICA terminus, AcomA, MCA or BA.
• Bifurcation wide neck aneurysm.
• 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.

You may not qualify if:

• Vessel tortuosity precluding safe access and device deployment.
• Stenosis within the vascular access or target vessel ≥ 50 %.
• The target aneurysm has been previously treated with a stent or an intraaneurysmal implant beside coils.
• The treatment plan for the target aneurysm includes the use of additional intra- and/or extraaneurysmal temporary or permanent implants other than coils.
• More than one intracerebral aneurysm requires the treatment within the following 6 months.
• Imaging evidence of an arteriovenous cerebrovascular malformation or a dural fistula.
• Any physical, medical or psychiatric condition of the patient interfering with the adherence of the requirements and follow-up regimen of the study.
• Any neurological disorder with progressive neurological symptoms, except attributable to a compressive effect of the target aneurysm.
• Current involvement in another study or trial.
• Women of child bearing potential or breast-feeding who cannot provide a negative pregnancy test.
• Known allergy to the components of device, study medication or contrast media that cannot be controlled medically.
• A medical condition interfering with a dual antiplatelet treatment.
• Known coagulopathy.
• Intracranial hemorrhage in the past 30 days apart from the target aneurysm.
• Ischemic stroke in the past 30 days.

Sponsors & Collaborators

• Phenox GmbH: lead

Study Sites (10)

Clínica La Sagrada Familia Department of Neuroscience (P.L.), Equipo de Neurocirugía Endovascular y Radiología Intervencionista

Buenos Aires, Buenos Aires F.D., 1642, Argentina

Location

LKH-Univ. Klinikum Graz Universitätsklinik für Radiologie

Graz, 8036, Austria

Location

Hôpital Pierre Wertheimer (HCL Groupement Hospitalier Est)

Bron, 69500, France

Location

KRH Klinikum Nordstadt

Hanover, Lower Saxony, 30167, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Gemeinschaftsklinikum Mittelrhein gGmbH

Koblenz, 56068, Germany

Location

Klinikum Osnabrück

Osnabrück, 49076, Germany

Location

Knappschaftskrankenhaus Recklinghausen

Recklinghausen, 45657, Germany

Location

Klinikum Stuttgart Katharinenhospital

Stuttgart, 70174, Germany

Location

A.S.L. Napoli 1 Centro - P.O. San Giovanni Bosco

Napoli, 80145, Italy

Location

Related Publications (1)

• 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.

  PMID: 35160333 BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm; Stroke

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alessandra Biondi, Prof. Dr.

  Hôpital Jean Minjoz (CHU Besançon), France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 18, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

AU (1); IT (1); AR (1); DE (6); FR (1)