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

November 19, 2020 updated by: 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1642
        • Clínica La Sagrada Familia
  • Belgium
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg
  • Bulgaria
      • Sofia, Bulgaria, 1431
        • St. Ivan Rilski Hospital
  • France
      • Bordeaux, France, 33000
        • Groupe Hospitalier Pellegrin
      • Bron, France, 69500
        • Hopital Pierre Wertheimer
      • Le Kremlin-Bicêtre Cedex, France, 94275
        • Hôpital Bicêtre
      • Montpellier, France, 34295
        • Hôpital Gui de Chauliac (CHU Montpellier)
      • Paris, France
        • Hôpital Pitié Salpêtrière
      • Reims, France
        • CHRU Hôpital Maison-Blanche
      • Tours cedex 9, France, 37044
        • Hôpital Bretonneau (CHRU de Tours)
  • Germany
      • Augsburg, Germany, 86156
        • Klinikum Augsburg
      • Bremen, Germany, 28205
        • Klinikum Bremen-Mitte
      • Erfurt, Germany
        • Helios Klinikum Erfurt
      • Recklinghausen, Germany, 45657
        • Knappschaftskrankenhaus Recklinghausen
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg
      • Stuttgart, Germany, 70174
        • Klinikum Stuttgart Katharinenhospital
  • Italy
      • Bologna, Italy
        • Ospedale Bellaria Carlo Alberto Pizzardi
      • Rozzano, Italy, 20089
        • IRCCS Istituto Clinico Humanitas
  • Poland
      • Grudziądz, Poland, 86-300
        • Regionalny Szpital Specjalistyczny
      • Wrocław, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny we Wroclawiu
  • Romania
      • Bucharest, Romania, 010718
        • Life Memorial Hospital
  • Russian Federation
      • Moscow, Russian Federation
        • NSI Burdenko, Moscow
      • Saint Petersburg, Russian Federation
        • Federal Almazov North-West Medical Research Centre
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Leeds, United Kingdom, LS1 3EX
        • Leeds Teaching Hospitals NHS Trust
      • London, United Kingdom, SW17 0QT
        • St George's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the rate of complete occlusion
Time Frame: 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.
immediately after treatment, an expected average of 1 hour; to 12 months
Change of frequency of major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
Time Frame: 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.
immediately after treatment, an expected average of 1 hour; to 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phenox GmbH

Investigators

  • Principal Investigator: Alain Bonafé, Prof. Dr., Hôpital Gui de Chauliac (CHU de Montpellier), Montpellier, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP64/BO1507

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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