Clinical trial NCT02554708: pCONus Treatment of Wide Neck Intracranial Aneurysms
Official title: pToWin pCONus Treatment of Wide Neck Intracranial Aneurysms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Keywords: Aneurysm
bifurcation
wide neck
pCONus
intracerebral
stroke
Lead sponsor: Phenox GmbH
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness Aneurysm occlusion (complete or neck remnant)
timeFrame: Change from post-procedure to 3-6 and to 7-12 months
measure: Safety Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
timeFrame: within 12 months
Secondary outcomes:
measure: Effectiveness
timeFrame: at the time of the procedure
measure: Safety Intra-Procedural Complications
timeFrame: at the time of the procedure
measure: Safety Post-Procedural Complications
timeFrame: Change 1day post procedure up to 12months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Clínica La Sagrada Familia Department of Neuroscience (P.L.), Equipo de Neurocirugía Endovascular y Radiología Intervencionista
state: Ciudad Autónoma De Buenos Aires
city: Graz
country: Austria
facility: LKH-Univ. Klinikum Graz Universitätsklinik für Radiologie
city: Bron cedex
country: France
facility: Hôpital Pierre Wertheimer (HCL Groupement Hospitalier Est)
city: Hannover
country: Germany
facility: KRH Klinikum Nordstadt
state: Niedersachsen
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Koblenz
country: Germany
facility: Gemeinschaftsklinikum Mittelrhein gGmbH
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück
city: Recklinghausen
country: Germany
facility: Knappschaftskrankenhaus Recklinghausen
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart Katharinenhospital
city: Napoli
country: Italy
facility: A.S.L. Napoli 1 Centro - P.O. San Giovanni Bosco
Study officials:
affiliation: Hôpital Jean Minjoz (CHU Besançon), France
name: Alessandra Biondi, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.