pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2

NCT03273478 | Unknown DMC

• 1 other identifier: PTW2/PH/20170823
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Intracranial Aneurysm

Keywords

Bifurcation aneurysm; Unruptured bifurcation aneurysm; Ruptured bifurcation aneurysm; Stent-assisted coiling; pCONUS2 Bifurcation Aneurysm Implant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":

  at the time of the procedure

• Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":

  at the time of the procedure

• Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":

  at the time of the procedure

• Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":

  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":

  at the time of the procedure

Interventions

Endovascular treatment of bifurcation aneurysm with pCONUS2 DEVICE

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.

Eligibility Criteria

• Age: 18 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 pCONUS2-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.
• 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 pCONUS2 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

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Konopka

CONTACT

+49 0234 36919; pToWin2@phenox.info

Treffner, Dr.

CONTACT

+49 0234 36919; pToWin2@phenox.info

Study Design

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

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: September 6, 2017
• Study Start: December 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 5, 2018

Record last verified: 2018-04