AzTrials
AzTrials

Intracranial AneurysmpToWinNCT02554708

pCONus Treatment of Wide Neck Intracranial Aneurysms

An observational study of Intracranial Aneurysm, run by Phenox GmbH at 10 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Intracranial Aneurysm
What is being tested?
implantation of the pCONus Bifurcation Aneurysm Implant
Type of treatment
Medical device
How many people
116 participants
Where
10 sitesin 5 countries
Study dates
Aug 2015to Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients harbouring an unruptured or ruptured bifurcation aneurysm, in which pCONus assisted coiling was judged to be the most appropriate treatment

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Myocardial infarction in the past 30 days.
  • Major surgery in the past 30 days.
  • Evidence of active infection at time of treatment.
  • Co -morbidities or conditions with a life expectancy less than 12 months.
  • Additional Exclusion criteria for ruptured aneurysm at the acute phase:
  • The patient is clinically severely affected (Hunt and Hess grade IV and V).
  • Severe vasospasm is proven during angiography.
  • Proven parenchymal hemorrhage by CT or MRI.
  • Proven subdural hematoma by CT or MRI.

Trial locations and contacts

10 sites in 5 countries.

10 sites in 5 countries

Germany6 sites

  • KRH Klinikum Nordstadt

    Hanover, Lower Saxony, 30167

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Gemeinschaftsklinikum Mittelrhein gGmbH

    Koblenz, 56068

  • Klinikum Osnabrück

    Osnabrück, 49076

  • Knappschaftskrankenhaus Recklinghausen

    Recklinghausen, 45657

  • Klinikum Stuttgart Katharinenhospital

    Stuttgart, 70174

Other trials in Germany

Argentina1 site

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

    Buenos Aires, Buenos Aires F.D., 1642

Other trials in Argentina

Austria1 site

  • LKH-Univ. Klinikum Graz Universitätsklinik für Radiologie

    Graz, 8036

Other trials in Austria

France1 site

  • Hôpital Pierre Wertheimer (HCL Groupement Hospitalier Est)

    Bron, 69500

Other trials in France

Italy1 site

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

    Naples, 80145

Other trials in Italy

About this study

Official title: pToWin pCONus Treatment of Wide Neck Intracranial Aneurysms

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

Read the 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

Being tested
implantation of the pCONus Bifurcation Aneurysm Implant
Keywords
Aneurysm, bifurcation, wide neck, pCONus, intracerebral, stroke
Medical subject headings
Intracranial Aneurysm, Aneurysm, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • implantation of the pCONus Bifurcation Aneurysm ImplantDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness Aneurysm occlusion (complete or neck remnant)

    Measured: Change from post-procedure to 3-6 and to 7-12 months

  2. Safety Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm

    Measured: within 12 months

Secondary outcomes (3)

  1. 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

    Measured: at the time of the procedure

  2. 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

    Measured: at the time of the procedure

  3. 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

    Measured: Change 1day post procedure up to 12months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionOct 2019
  4. Study completionOct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02554708
Sponsor's protocol ID
PTW/PV201505-21
Acronym
pToWin
Status last verified
Sep 2022
First submitted
4 Sep 2015
Last updated
29 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 35160333

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Aneurysm, run by Phenox GmbH at 10 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, Argentina, Austria, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness Aneurysm occlusion (complete or neck remnant) (time frame: Change from post-procedure to 3-6 and to 7-12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02554708, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.

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