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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-11

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Aneurysm Arteriovenous Malformations Arterio-venous Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients are over 18 years of age.
* Patients will undergo catheter embolization using the Kaneka ED Coil with the ED Detach Generator v4 for aneurysm, arteriovenous malformation (AVM), or arteriovenous fistula (AFV)
* The patient, or his/her representative, has agreed to the informed consent.