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

Kaneka

Status: Unknown

Conditions: Arterio-venous Fistula; Aneurysm; Arteriovenous Malformations

Treatments: Device: ED Coil / Electro-detach Generator v4

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03853070

ED Coil Prosp

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

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