Diversion-p64 Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device

Completed

• Conditions: Intracranial Aneurysm

• Registration Number: NCT02600364
• Lead Sponsor: Phenox GmbH

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.

Study Timeline

• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Study Start: 2015-12
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of frequency of major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm	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.
Change in the rate of complete occlusion	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.

Secondary Outcome Measures

Name	Time	Method
Intra-procedural vascular complications	during treatment, an expected average of 1 hour	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
Intra-procedural technical complications	during treatment, an expected average of 1 hour	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
Post-procedural Complications	3-6 and 7-12 months	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
Change of Angiographic results	immediately after treatment, an expected average of 1 hour; to 12 months	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).

Trial Locations

Locations (26)

Clínica La Sagrada Familia; 🇦🇷 Buenos Aires, Argentina

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

St. Ivan Rilski Hospital; 🇧🇬 Sofia, Bulgaria

Hôpital Pierre Wertheimer; 🇫🇷 Bron, France

Hôpital Gui de Chauliac (CHU Montpellier); 🇫🇷 Montpellier, France

Hôpital Pitié Salpétrière; 🇫🇷 Paris, France

Hôpital Bretonneau (CHRU de Tours); 🇫🇷 Tours cedex 9, 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

Regionalny Szpital Specjalistyczny; 🇵🇱 Grudziądz, Poland

NSI Burdenko, Moscow; 🇷🇺 Moscow, Russian Federation

Federal Almazov North-West Medical Research Centre; 🇷🇺 Saint Petersburg, Russian Federation

Leeds Teaching Hospitals NHS TRUST; 🇬🇧 Leeds, United Kingdom

St George's Hospital; 🇬🇧 London, United Kingdom

Ospedale Bellaria Carlo Alberto Pizzardi; 🇮🇹 Bologna, Italy

IRCCS Istituto Clinico Humanitas; 🇮🇹 Rozzano, Italy

Life Memorial Hospital; 🇷🇴 Bucharest, Romania

Groupe Hospitalier Pellegrin; 🇫🇷 Bordeaux, France

Hôpital Bicêtre; 🇫🇷 Le Kremlin-Bicêtre Cedex, France

CHRU Hôpital Maison-Blanche; 🇫🇷 Reims, France

Western General Hospital; 🇬🇧 Edinburgh, United Kingdom

Uniwersytecki Szpital Kliniczny we Wroclawiu; 🇵🇱 Wrocław, Poland