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

• Conditions: Arterio-venous Fistula; Arteriovenous Malformations; Aneurysm

• Registration Number: NCT03853070
• Lead Sponsor: Kaneka Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-11
• Status Verified: 2019-02
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-21
• Last Update Submitted: 2019-02-21
• Study First Posted: 2019-02-25
• Last Update Posted: 2019-02-25
• Primary Completion: 2019-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance Measure	At 12 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 the the number of detachment attempts

Trial Locations

Locations (3)

UZA Atwerp; 🇧🇪 Edegem, Antwerp, Belgium

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

Knappschaftskrankenhaus Bochum; 🇩🇪 Bochum, Nordrhein-Westfalen, Germany