Intracranial AneurysmpToWin2NCT03273478
pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2
An observational study of Intracranial Aneurysm, run by Phenox GmbH.
Trial summary
To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Endovascular treatment of bifurcation aneurysm with pCONUS2
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients harbouring an unruptured or ruptured bifurcation aneurysm, in which pCONUS2-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.
- 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 pCONUS2 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
No sites are listed yet.
About this study
To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation aneurysms.
Read the detailed description
Title: pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2
Acronym: pToWin2
Device: pCONUS2 Bifurcation Aneurysm Implant
Study design: Prospective, multicenter, single-arm clinical investigation
Purpose: To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation aneurysms
Duration of the study: 30 months
Sample size: 100 evaluable patients
Number of sites: max. 15
Follow-up intervals: Two independent follow-ups (after 3-6 and 7-12 months) according to site specific standard
- Conditions
- Intracranial Aneurysm
- Being tested
- Endovascular treatment of bifurcation aneurysm with pCONUS2
- Keywords
- Bifurcation aneurysm, Unruptured bifurcation aneurysm, Ruptured bifurcation aneurysm, Stent-assisted coiling, pCONUS2 Bifurcation Aneurysm Implant
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatment of bifurcation aneurysm with pCONUS2Device
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: Aneurysm occlusion (complete or neck remnant)
Assessment by Raymond-Roy occlusion scale
Measured: Change from post-procedure to 12 months
Safety: Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
Measured: within 12 months
Secondary outcomes (16)
Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":
- To place pCONUS2 in the desired location
Measured: at the time of the procedure
Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":
- Correct opening of the device (crown and shaft)
Measured: at the time of the procedure
Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":
- To perform aneurysm occlusion without obliteration of side branches
Measured: at the time of the procedure
Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":
- To detach the device at the end of the procedure
Measured: 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":
- Vessel perforation
Measured: 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":
- Target aneurysm perforation with microcatheter or guidewire
Measured: 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":
- Target aneurysm perforation with pCONUS2
Measured: 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":
- Target aneurysm perforation with coils
Measured: 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":
- Thromboembolism
Measured: 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":
- Dissection of any access vessel
Measured: 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":
- Frequency of new parenchymal hemorrhage
Measured: Change 1day post procedure up to 12months
Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
- Frequency of new subarachnoid hemorrhage
Measured: Change 1day post procedure up to 12months
Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
- Frequency of new ischemic stroke
Measured: Change 1day post procedure up to 12months
Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
- Rupture of the target aneurysm
Measured: Change 1day post procedure up to 12months
Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
- Rate of in-stent-stenosis
Measured: Change 1day post procedure up to 12months
Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
- 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.
- First posted6 Sep 2017
- Study startDec 2018 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phenox GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273478
- Sponsor's protocol ID
- PTW2/PH/20170823
- Acronym
- pToWin2
- Status last verified
- Apr 2018
- First submitted
- 23 Aug 2017
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2
- ClinicalTrials.gov ID
- NCT03273478
- Acronym / sponsor ID
- pToWin2 / PTW2/PH/20170823
- Conditions
- Intracranial Aneurysm
- Keywords
- Bifurcation aneurysm, Unruptured bifurcation aneurysm, Ruptured bifurcation aneurysm, Stent-assisted coiling, pCONUS2 Bifurcation Aneurysm Implant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Phenox GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation aneurysms.
Detailed description
Title: pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2
Acronym: pToWin2
Device: pCONUS2 Bifurcation Aneurysm Implant
Study design: Prospective, multicenter, single-arm clinical investigation
Purpose: To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation aneurysms
Duration of the study: 30 months
Sample size: 100 evaluable patients
Number of sites: max. 15
Follow-up intervals: Two independent follow-ups (after 3-6 and 7-12 months) according to site specific standard
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients harbouring an unruptured or ruptured bifurcation aneurysm, in which pCONUS2-assisted coiling was judged to be the most appropriate treatment
Key inclusion criteria (9 listed)
- Aneurysm status:
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular treatment of bifurcation aneurysm with pCONUS2Patients 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. | Device | – |
Primary outcome
Effectiveness: Aneurysm occlusion (complete or neck remnant)
Time frame: Change from post-procedure to 12 months
Assessment by Raymond-Roy occlusion scale
Safety: Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
Time frame: within 12 months
16 secondary outcomes
Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":
Time frame: at the time of the procedure
Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":
Time frame: at the time of the procedure
Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":
Time frame: at the time of the procedure
Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":
Time frame: 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":
Time frame: 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":
Time frame: 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":
Time frame: 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":
Time frame: 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":
Time frame: 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":
Time frame: 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":
Time frame: Change 1day post procedure up to 12months
Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
Time frame: Change 1day post procedure up to 12months
Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
Time frame: Change 1day post procedure up to 12months
Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
Time frame: Change 1day post procedure up to 12months
Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
Time frame: Change 1day post procedure up to 12months
Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
Time frame: Change 1day post procedure up to 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Phenox GmbH.
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: status not confirmed, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konopka (+49 0234 36919 ext. 0, pToWin2@phenox.info), or a site near the patient. 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 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?
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 5 Apr 2018.