Clinical trial NCT02600364: Diversion-p64 Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device
Official title: Prospective, Multicenter, Single Arm Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Keywords: Aneurysm
intracerebral
stroke
p64
Lead sponsor: Phenox GmbH
Sponsor class: INDUSTRY
First posted: 2015-11-09
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria

1. Age ≥ 18
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

1. Aneurysms of the posterior circulation
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

Primary outcomes:
measure: Change in the rate of complete occlusion
timeFrame: immediately after treatment, an expected average of 1 hour; to 12 months
measure: Change of frequency of major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
timeFrame: immediately after treatment, an expected average of 1 hour; to 12 months
Secondary outcomes:
measure: Intra-procedural technical complications
timeFrame: during treatment, an expected average of 1 hour
measure: Change of Angiographic results
timeFrame: immediately after treatment, an expected average of 1 hour; to 12 months
measure: Intra-procedural vascular complications
timeFrame: during treatment, an expected average of 1 hour
measure: Post-procedural Complications
timeFrame: 3-6 and 7-12 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Clínica La Sagrada Familia
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Sofia
country: Bulgaria
facility: St. Ivan Rilski Hospital
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Bron
country: France
facility: Hôpital Pierre Wertheimer
city: Le Kremlin-Bicêtre Cedex
country: France
facility: Hôpital Bicêtre
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac (CHU Montpellier)
city: Paris
country: France
facility: Hôpital Pitié Salpétrière
city: Reims
country: France
facility: CHRU Hôpital Maison-Blanche
city: Tours cedex 9
country: France
facility: Hôpital Bretonneau (CHRU de Tours)
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bremen
country: Germany
facility: Klinikum Bremen-Mitte
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt
city: Recklinghausen
country: Germany
facility: Knappschaftskrankenhaus Recklinghausen
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart Katharinenhospital
city: Bologna
country: Italy
facility: Ospedale Bellaria Carlo Alberto Pizzardi
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: Grudziądz
country: Poland
facility: Regionalny Szpital Specjalistyczny
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny we Wroclawiu
city: Bucharest
country: Romania
facility: Life Memorial Hospital
city: Moscow
country: Russian Federation
facility: NSI Burdenko, Moscow
city: Saint Petersburg
country: Russian Federation
facility: Federal Almazov North-West Medical Research Centre
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS TRUST
city: London
country: United Kingdom
facility: St George's Hospital
Study officials:
affiliation: Hôpital Gui de Chauliac (CHU de Montpellier), Montpellier, France
name: Alain Bonafé, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: