Diversion-p64 Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device
Prospective, Multicenter, Single Arm Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device
1 other identifier
observational
450
10 countries
26
Brief Summary
The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2015
CompletedFirst Posted
Study publicly available on registry
November 9, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedNovember 20, 2020
November 1, 2020
4.5 years
November 4, 2015
November 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
immediately after treatment, an expected average of 1 hour; to 12 months
Secondary Outcomes (4)
Intra-procedural technical complications
during treatment, an expected average of 1 hour
Change of Angiographic results
immediately after treatment, an expected average of 1 hour; to 12 months
Intra-procedural vascular complications
during treatment, an expected average of 1 hour
Post-procedural Complications
3-6 and 7-12 months
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Phenox GmbHlead
Study Sites (26)
Clínica La Sagrada Familia
Buenos Aires, 1642, Argentina
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
St. Ivan Rilski Hospital
Sofia, 1431, Bulgaria
Groupe Hospitalier Pellegrin
Bordeaux, 33000, France
Hôpital Pierre Wertheimer
Bron, 69500, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275, France
Hôpital Gui de Chauliac (CHU Montpellier)
Montpellier, 34295, France
Hôpital Pitié Salpétrière
Paris, France
CHRU Hôpital Maison-Blanche
Reims, France
Hôpital Bretonneau (CHRU de Tours)
Tours, 37044, France
Klinikum Augsburg
Augsburg, 86156, Germany
Klinikum Bremen-Mitte
Bremen, 28205, Germany
HELIOS Klinikum Erfurt
Erfurt, Germany
Knappschaftskrankenhaus Recklinghausen
Recklinghausen, 45657, Germany
Universitätsklinikum Regensburg
Regensburg, 93053, Germany
Klinikum Stuttgart Katharinenhospital
Stuttgart, 70174, Germany
Ospedale Bellaria Carlo Alberto Pizzardi
Bologna, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, 20089, Italy
Regionalny Szpital Specjalistyczny
Grudziądz, 86-300, Poland
Uniwersytecki Szpital Kliniczny we Wroclawiu
Wroclaw, 50-556, Poland
Life Memorial Hospital
Bucharest, 010718, Romania
NSI Burdenko, Moscow
Moscow, Russia
Federal Almazov North-West Medical Research Centre
Saint Petersburg, Russia
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Leeds Teaching Hospitals NHS TRUST
Leeds, LS1 3EX, United Kingdom
St George's Hospital
London, SW17 0QT, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alain Bonafé, Prof. Dr.
Hôpital Gui de Chauliac (CHU de Montpellier), Montpellier, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2015
First Posted
November 9, 2015
Study Start
December 1, 2015
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
November 20, 2020
Record last verified: 2020-11