Diversion-p64 Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device
NCT ID: NCT02600364
Last Updated: 2020-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
450 participants
OBSERVATIONAL
2015-12-31
2020-06-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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)
Exclusion Criteria
2. Imaging evidence of bifurcation aneurysms
3. Imaging evidence of dissections
4. Imaging evidence of fistulae
5. Imaging evidence of arteriovenous malformations
6. Patient is harbouring another aneurysm that has to be treated within six months after first procedure
7. Known allergy to study medication, e.g. ASA, Clopidogrel, Heparin or contrast media
8. Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)
9. Current involvement in another study or trial
10. Parent vessel treated with other Flow Diverters than p64 during intervention and re-treatment
18 Years
ALL
No
Sponsors
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Phenox GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Alain Bonafé, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Hôpital Gui de Chauliac (CHU de Montpellier), Montpellier, France
Locations
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Clínica La Sagrada Familia
Buenos Aires, , Argentina
Ziekenhuis Oost-Limburg
Genk, , Belgium
St. Ivan Rilski Hospital
Sofia, , Bulgaria
Groupe Hospitalier Pellegrin
Bordeaux, , France
Hôpital Pierre Wertheimer
Bron, , France
Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Hôpital Gui de Chauliac (CHU Montpellier)
Montpellier, , France
Hôpital Pitié Salpétrière
Paris, , France
CHRU Hôpital Maison-Blanche
Reims, , France
Hôpital Bretonneau (CHRU de Tours)
Tours, , France
Klinikum Augsburg
Augsburg, , Germany
Klinikum Bremen-Mitte
Bremen, , Germany
HELIOS Klinikum Erfurt
Erfurt, , Germany
Knappschaftskrankenhaus Recklinghausen
Recklinghausen, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
Klinikum Stuttgart Katharinenhospital
Stuttgart, , Germany
Ospedale Bellaria Carlo Alberto Pizzardi
Bologna, , Italy
IRCCS Istituto Clinico Humanitas
Rozzano, , Italy
Regionalny Szpital Specjalistyczny
Grudziądz, , Poland
Uniwersytecki Szpital Kliniczny we Wroclawiu
Wroclaw, , Poland
Life Memorial Hospital
Bucharest, , Romania
NSI Burdenko, Moscow
Moscow, , Russia
Federal Almazov North-West Medical Research Centre
Saint Petersburg, , Russia
Western General Hospital
Edinburgh, , United Kingdom
Leeds Teaching Hospitals NHS TRUST
Leeds, , United Kingdom
St George's Hospital
London, , United Kingdom
Countries
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Related Links
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www.phenox.net
Other Identifiers
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DP64/BO1507
Identifier Type: -
Identifier Source: org_study_id