Diversion-p64 Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device
19. november 2020 opdateret af: Phenox GmbH
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
450
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina, 1642
- Clínica La Sagrada Familia
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Genk, Belgien, 3600
- Ziekenhuis Oost-Limburg
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Sofia, Bulgarien, 1431
- St. Ivan Rilski Hospital
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Moscow, Den Russiske Føderation
- NSI Burdenko, Moscow
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Saint Petersburg, Den Russiske Føderation
- Federal Almazov North-West Medical Research Centre
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Edinburgh, Det Forenede Kongerige, EH4 2XU
- Western General Hospital
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Leeds, Det Forenede Kongerige, LS1 3EX
- Leeds Teaching Hospitals NHS Trust
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London, Det Forenede Kongerige, SW17 0QT
- St George's Hospital
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Bordeaux, Frankrig, 33000
- Groupe hospitalier Pellegrin
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Bron, Frankrig, 69500
- Hôpital Pierre Wertheimer
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Le Kremlin-Bicêtre Cedex, Frankrig, 94275
- Hôpital Bicêtre
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Montpellier, Frankrig, 34295
- Hôpital Gui de Chauliac (CHU Montpellier)
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Paris, Frankrig
- Hôpital Pitié Salpêtrière
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Reims, Frankrig
- CHRU Hôpital Maison-Blanche
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Tours cedex 9, Frankrig, 37044
- Hôpital Bretonneau (CHRU de Tours)
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Bologna, Italien
- Ospedale Bellaria Carlo Alberto Pizzardi
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Rozzano, Italien, 20089
- IRCCS Istituto Clinico Humanitas
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Grudziądz, Polen, 86-300
- Regionalny Szpital Specjalistyczny
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Wrocław, Polen, 50-556
- Uniwersytecki Szpital Kliniczny we Wroclawiu
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Bucharest, Rumænien, 010718
- Life Memorial Hospital
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Augsburg, Tyskland, 86156
- Klinikum Augsburg
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Bremen, Tyskland, 28205
- Klinikum Bremen-Mitte
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Erfurt, Tyskland
- Helios Klinikum Erfurt
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Recklinghausen, Tyskland, 45657
- Knappschaftskrankenhaus Recklinghausen
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Regensburg, Tyskland, 93053
- Universitätsklinikum Regensburg
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Stuttgart, Tyskland, 70174
- Klinikum Stuttgart Katharinenhospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in the rate of complete occlusion
Tidsramme: immediately after treatment, an expected average of 1 hour; to 12 months
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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.
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immediately after treatment, an expected average of 1 hour; to 12 months
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Change of frequency of major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
Tidsramme: immediately after treatment, an expected average of 1 hour; to 12 months
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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.
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immediately after treatment, an expected average of 1 hour; to 12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Intra-procedural technical complications
Tidsramme: during treatment, an expected average of 1 hour
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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
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during treatment, an expected average of 1 hour
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Change of Angiographic results
Tidsramme: immediately after treatment, an expected average of 1 hour; to 12 months
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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).
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immediately after treatment, an expected average of 1 hour; to 12 months
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Intra-procedural vascular complications
Tidsramme: during treatment, an expected average of 1 hour
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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
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during treatment, an expected average of 1 hour
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Post-procedural Complications
Tidsramme: 3-6 and 7-12 months
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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
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3-6 and 7-12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Alain Bonafé, Prof. Dr., Hôpital Gui de Chauliac (CHU de Montpellier), Montpellier, France
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. december 2015
Primær færdiggørelse (Faktiske)
1. juni 2020
Studieafslutning (Faktiske)
1. juni 2020
Datoer for studieregistrering
Først indsendt
4. november 2015
Først indsendt, der opfyldte QC-kriterier
6. november 2015
Først opslået (Skøn)
9. november 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. november 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. november 2020
Sidst verificeret
1. november 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DP64/BO1507
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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