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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03853070

Enrollment

100

Registered

2019-02-25

Start date

2018-12-11

Completion date

2021-12-31

Last updated

2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm, Arterio-venous Fistula, Arteriovenous Malformations

Brief 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.

Interventions

DEVICEED 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Performance Measure	At 6 months	The recanalization in aneurysms will be classified using the Raymond-Roy Classification. The outcomes following embolization of arteriovenous malformations and arteriovenous fistula will be classified as follows complete occlusion/subtotal occlusion/ partial occlusion
Safety Measure - Assessment of Adverse Events	During 12 months	All adverse events will be recorded, along with their seriousness and relatedness to the device or the procedure.
Technical Measure	At embolization procedure, an average of 1 week	The technical properties of the ED Electrodetach Generator v4 will be assessed by successful coil detachment (yes/no)

Countries

Belgium, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026