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

Intracranial Aneurysm Clinical Trial

Official title:

Prospective, Multicenter, Single Arm Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600364
• Other study ID #: DP64/BO1507
• Status: Completed
• Start date: December 2015
• Est. completion date: June 2020

Study information

• Verified date: November 2020
• Source: Phenox GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Locations

Country	Name	City	State
Argentina	Clínica La Sagrada Familia	Buenos Aires
Belgium	Ziekenhuis Oost-Limburg	Genk
Bulgaria	St. Ivan Rilski Hospital	Sofia
France	Groupe Hospitalier Pellegrin	Bordeaux
France	Hôpital Pierre Wertheimer	Bron
France	Hôpital Bicêtre	Le Kremlin-Bicêtre Cedex
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 cedex 9
Germany	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
Italy	Ospedale Bellaria Carlo Alberto Pizzardi	Bologna
Italy	IRCCS Istituto Clinico Humanitas	Rozzano
Poland	Regionalny Szpital Specjalistyczny	Grudziadz
Poland	Uniwersytecki Szpital Kliniczny we Wroclawiu	Wroclaw
Romania	Life Memorial Hospital	Bucharest
Russian Federation	NSI Burdenko, Moscow	Moscow
Russian Federation	Federal Almazov North-West Medical Research Centre	Saint Petersburg
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Leeds Teaching Hospitals NHS TRUST	Leeds
United Kingdom	St George's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Phenox GmbH

Countries where clinical trial is conducted

Argentina,  Belgium,  Bulgaria,  France,  Germany,  Italy,  Poland,  Romania,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Intra-procedural technical complications	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	during treatment, an expected average of 1 hour
Secondary	Change of Angiographic results	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).	immediately after treatment, an expected average of 1 hour; to 12 months
Secondary	Intra-procedural vascular complications	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	during treatment, an expected average of 1 hour
Secondary	Post-procedural Complications	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	3-6 and 7-12 months

External Links

•   www.phenox.net