Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4

Last updated: February 21, 2019
Sponsor: Kaneka Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Birth Defects

Hemangioma

Treatment

N/A

Clinical Study ID

NCT03853070
ED Coil Prosp
  • Ages > 18
  • All Genders

Study Summary

This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients are over 18 years of age.

  • Patients will undergo catheter embolization using the Kaneka ED Coil with the EDDetach Generator v4 for aneurysm, arteriovenous malformation (AVM), or arteriovenousfistula (AFV)

  • The patient, or his/her representative, has agreed to the informed consent.

Exclusion

Exclusion Criteria:

  • The patient, or his/her representative, is unwilling or unable to agree to theinformed consent.

Study Design

Total Participants: 100
Study Start date:
December 11, 2018
Estimated Completion Date:
December 31, 2021

Connect with a study center

  • UZA Atwerp

    Edegem, Antwerp 2650
    Belgium

    Site Not Available

  • Knappschaftskrankenhaus Bochum

    Bochum, Nordrhein-Westfalen 44892
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein 23538
    Germany

    Active - Recruiting

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