Intracranial AneurysmNCT02600364
Diversion-p64 Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device
An observational study of Intracranial Aneurysm, run by Phenox GmbH at 26 sites in 10 countries.
Trial summary
The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm
- How many people
- 450 participants
- Where
- 26 sitesin 10 countries
- Study dates
- Dec 2015to Jun 2020
- 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: The target population for this non-interventional study are patients with ruptured or unruptured aneurysms and segmental diseases in the anterior circulation. Patients can be included in the study if they meet all of the inclusion and none of the exclusion criteria and have provided written informed consent.
Who may be able to join
- Age ≥ 18
- Patient harbours either one saccular or one dissecting or one blisterlike or one fusiform intracerebral aneurysm or one intracerebral segmental disease, in the anterior circulation for which the indication for p64 treatment is given
- Patient or legal representative provides written informed consent verifying that he/she consents to the use of his/her data (according to the data protection laws)
Who cannot join
- Aneurysms of the posterior circulation
- Imaging evidence of bifurcation aneurysms
- Imaging evidence of dissections
- Imaging evidence of fistulae
- Imaging evidence of arteriovenous malformations
- Patient is harbouring another aneurysm that has to be treated within six months after first procedure
Show all 10Show fewer
- Known allergy to study medication, e.g. ASA, Clopidogrel, Heparin or contrast media
- Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)
- Current involvement in another study or trial
- Parent vessel treated with other Flow Diverters than p64 during intervention and re-treatment
Trial locations and contacts
26 sites in 10 countries.
26 sites in 10 countries
France7 sites
Groupe Hospitalier Pellegrin
Bordeaux, 33000
Hôpital Pierre Wertheimer
Bron, 69500
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
Hôpital Gui de Chauliac (CHU Montpellier)
Montpellier, 34295
Hôpital Pitié Salpétrière
Paris
CHRU Hôpital Maison-Blanche
Reims
Hôpital Bretonneau (CHRU de Tours)
Tours, 37044
Germany6 sites
Klinikum Augsburg
Augsburg, 86156
Klinikum Bremen-Mitte
Bremen, 28205
HELIOS Klinikum Erfurt
Erfurt
Knappschaftskrankenhaus Recklinghausen
Recklinghausen, 45657
Universitätsklinikum Regensburg
Regensburg, 93053
Klinikum Stuttgart Katharinenhospital
Stuttgart, 70174
United Kingdom3 sites
Western General Hospital
Edinburgh, EH4 2XU
Leeds Teaching Hospitals NHS TRUST
Leeds, LS1 3EX
St George's Hospital
London, SW17 0QT
Italy2 sites
Ospedale Bellaria Carlo Alberto Pizzardi
Bologna
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
Poland2 sites
Regionalny Szpital Specjalistyczny
Grudziądz, 86-300
Uniwersytecki Szpital Kliniczny we Wroclawiu
Wroclaw, 50-556
Russia2 sites
NSI Burdenko, Moscow
Moscow
Federal Almazov North-West Medical Research Centre
Saint Petersburg
About this study
Official title: Prospective, Multicenter, Single Arm Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device
The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.
Read the detailed description
Title: Diversion-p64. Device: p64 Flow Modulation Device. Study design: Prospective, multicenter, single arm Post Market Clinical Follow-Up Study.
Purpose: To assess safety and effectiveness of p64. Study duration: 48 months. Sample Size: 400 patients. Number of sites: > 20. Follow-up intervals: Two independent follow-ups (after 3-6 and 7-12 months) according to site specific standard.
- Conditions
- Intracranial Aneurysm
- Keywords
- Aneurysm, intracerebral, stroke, p64
- Medical subject headings
- Intracranial Aneurysm, Aneurysm, Stroke, X-Linked Combined Immunodeficiency Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the rate of complete occlusion
Rate of complete aneurysm occlusion is assessed immediately after treatment (an expected average of 1 hour) and at both follow-up visits (3-6 months and 7-12 months). The change is assesed.
Measured: immediately after treatment, an expected average of 1 hour; to 12 months
Change of frequency of major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
Frequency of major stroke (ischemic or hemorrhagic) or neurological death is assessed immediately after treatment (an expected average of 1 hour) and at both follow-up visits (3-6 months and 7-12 months). The change is assesed.
Measured: immediately after treatment, an expected average of 1 hour; to 12 months
Secondary outcomes (4)
Intra-procedural technical complications
p64 placed in the desired location Correct opening of p64 (markers fully deployed) at the end of the procedure Ability to detach p64 at the end of the procedure
Measured: during treatment, an expected average of 1 hour
Change of Angiographic results
Change in both Rate of re-growth (related rate of re-treatment) and Rate of recanalization (related rate of re-treatment) are assessed immediately after treatment (an expected average of 1 hour) and at both follow-up visits (3-6 months and 7-12 months).
Measured: immediately after treatment, an expected average of 1 hour; to 12 months
Intra-procedural vascular complications
Vessel perforation (e.g. with distal wire tip of p64, microcatheter) Target aneurysm perforation (e.g. with distal wire tip of p64, microcatheter) Thromboembolism Dissection of any access vessel Side branch occlusion
Measured: during treatment, an expected average of 1 hour
Post-procedural Complications
Parenchymal hemorrhage detected during the follow-up period Subarachnoid hemorrhage detected during the follow-up period Ischemic stroke detected on follow-up imaging Rupture of the target aneurysm detected during the follow-up period Rate of in-stent-stenosis detected during the follow-up period
Measured: 3-6 and 7-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2020
- Study completionJun 2020
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
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phenox GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alain Bonafé, Prof. Dr., Principal investigator, Hôpital Gui de Chauliac (CHU de Montpellier), Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600364
- Sponsor's protocol ID
- DP64/BO1507
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2015
- Last updated
- 20 Nov 2020
- 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 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single Arm Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device
- ClinicalTrials.gov ID
- NCT02600364
- Acronym / sponsor ID
- DP64/BO1507
- Conditions
- Intracranial Aneurysm
- Keywords
- Aneurysm, intracerebral, stroke, p64
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Phenox GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 9 Nov 2015 (estimated)
- 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.
The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.
Detailed description
Title: Diversion-p64. Device: p64 Flow Modulation Device. Study design: Prospective, multicenter, single arm Post Market Clinical Follow-Up Study.
Purpose: To assess safety and effectiveness of p64. Study duration: 48 months. Sample Size: 400 patients. Number of sites: > 20. 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
- The target population for this non-interventional study are patients with ruptured or unruptured aneurysms and segmental diseases in the anterior circulation. Patients can be included in the study if they meet all of the inclusion and none of the exclusion criteria and have provided written informed consent.
Key inclusion criteria (3 listed)
- Age ≥ 18
- Patient harbours either one saccular or one dissecting or one blisterlike or one fusiform intracerebral aneurysm or one intracerebral segmental disease, in the anterior circulation for which the indication for p64 treatment is given
- Patient or legal representative provides written informed consent verifying that he/she consents to the use of his/her data (according to the data protection laws)
Key exclusion criteria (10 listed)
- Aneurysms of the posterior circulation
- Imaging evidence of bifurcation aneurysms
- Imaging evidence of dissections
- Imaging evidence of fistulae
- Imaging evidence of arteriovenous malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the rate of complete occlusion
Time frame: immediately after treatment, an expected average of 1 hour; to 12 months
Rate of complete aneurysm occlusion is assessed immediately after treatment (an expected average of 1 hour) and at both follow-up visits (3-6 months and 7-12 months). The change is assesed.
Change of frequency of major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
Time frame: immediately after treatment, an expected average of 1 hour; to 12 months
Frequency of major stroke (ischemic or hemorrhagic) or neurological death is assessed immediately after treatment (an expected average of 1 hour) and at both follow-up visits (3-6 months and 7-12 months). The change is assesed.
4 secondary outcomes
Intra-procedural technical complications
Time frame: during treatment, an expected average of 1 hour
Change of Angiographic results
Time frame: immediately after treatment, an expected average of 1 hour; to 12 months
Intra-procedural vascular complications
Time frame: during treatment, an expected average of 1 hour
Post-procedural Complications
Time frame: 3-6 and 7-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- www.phenox.netLink provided by the sponsor.
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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.
Alain Bonafé, Prof. Dr. principal investigator
Hôpital Gui de Chauliac (CHU de Montpellier), Montpellier, France
26 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Phenox GmbH at 26 sites in 10 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 3 inclusion and 10 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 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France, Germany, United Kingdom, Italy, Poland and 5 more countries. 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?
Change in the rate of complete occlusion (time frame: immediately after treatment, an expected average of 1 hour; 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 20 Nov 2020.