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Completed

NCT Number: NCT02600364

Diversion-p64 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.

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Immune System Diseases Immunologic Deficiency Syndromes Infant, Newborn, Diseases Intracranial Arterial Diseases Nervous System Diseases Primary Immunodeficiency Diseases Severe Combined Immunodeficiency Stroke Vascular Diseases X-Linked Combined Immunodeficiency Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica La Sagrada Familia, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18
  • 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
  • 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

  • Aneurysms of the posterior circulation
  • Imaging evidence of bifurcation aneurysms
  • Imaging evidence of dissections
  • Imaging evidence of fistulae
  • Imaging evidence of arteriovenous malformations
  • Patient is harbouring another aneurysm that has to be treated within six months after first procedure
  • Known allergy to study medication, e.g. ASA, Clopidogrel, Heparin or contrast media
  • Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)
  • Current involvement in another study or trial
  • Parent vessel treated with other Flow Diverters than p64 during intervention and re-treatment

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Phenox GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 9, 2015
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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