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

Kaneka Corporation100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Aneurysm Arteriovenous Malformations Arterio-venous Fistula

Interventions

ED Coil / Electro-detach Generator v4DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

UZA Atwerp

Edegem, Antwerp, Belgium

NOT_YET_RECRUITING

Knappschaftskrankenhaus Bochum

Bochum, North Rhine-Westphalia, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

RECRUITING

Outcomes

Primary Outcomes

Performance Measure

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

Time frame: At 6 months

Performance Measure

Time frame: At 12 months

Safety Measure - Assessment of Adverse Events

All adverse events will be recorded, along with their seriousness and relatedness to the device or the procedure.

Time frame: During 12 months

Technical Measure

The technical properties of the ED Electrodetach Generator v4 will be assessed by successful coil detachment (yes/no)

Time frame: At embolization procedure, an average of 1 week

Technical Measure

The technical properties of the ED Electrodetach Generator v4 will be assessed by the the number of detachment attempts

Time frame: At embolization procedure, an average of 1 week

Data from ClinicalTrials.gov

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