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

NCT03853070 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-02-25

No results posted yet for this 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.

Conditions

  • Aneurysm
  • Arteriovenous Malformations
  • Arterio-venous Fistula

Interventions

DEVICE

ED Coil / Electro-detach Generator v4

The ED Coil is used for vascular embolization with a platinum coil at the target lesion in a patient's blood vessel. The ED Detach Generator is intended to for use solely to detach the platinum coil from the delivery catheter of the ED Coil.

Sponsors & Collaborators

  • ClinSearch

    collaborator OTHER

  • Kaneka Corporation

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2019-12-31
Completion
2021-12-31

Countries

  • Belgium
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03853070 on ClinicalTrials.gov