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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02600364
Recruitment Status : Completed
First Posted : November 9, 2015
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Phenox GmbH

Study Description
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Brief Summary:
The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.

Condition or disease
Intracranial Aneurysm

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 Design
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Study Type : Observational
Actual Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Multicenter, Single Arm Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device
Actual Study Start Date : December 2015
Actual Primary Completion Date : June 2020
Actual Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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).

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600364


Locations
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Sponsors and Collaborators
Phenox GmbH
Investigators
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Principal Investigator: Alain Bonafé, Prof. Dr. Hôpital Gui de Chauliac (CHU de Montpellier), Montpellier, France
More Information
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Additional Information:

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Responsible Party: Phenox GmbH
ClinicalTrials.gov Identifier: NCT02600364    
Other Study ID Numbers: DP64/BO1507
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Phenox GmbH:
Aneurysm
intracerebral
stroke
p64
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases