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

Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03853070
• Other study ID #: ED Coil Prosp
• Status: Recruiting
• Start date: December 11, 2018
• Est. completion date: December 2021

Study information

• Verified date: February 2019
• Source: Kaneka Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Arterio-venous Fistula
• Arteriovenous Fistula
• Arteriovenous Malformations
• Congenital Abnormalities
• Fistula
• Hemangioma

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belgium	UZA Atwerp	Edegem	Antwerp
Germany	Knappschaftskrankenhaus Bochum	Bochum	Nordrhein-Westfalen
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
Kaneka Corporation	ClinSearch

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At 6 months
Primary	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	At 12 months
Primary	Safety Measure - Assessment of Adverse Events	All adverse events will be recorded, along with their seriousness and relatedness to the device or the procedure.	During 12 months
Primary	Technical Measure	The technical properties of the ED Electrodetach Generator v4 will be assessed by successful coil detachment (yes/no)	At embolization procedure, an average of 1 week
Primary	Technical Measure	The technical properties of the ED Electrodetach Generator v4 will be assessed by the the number of detachment attempts	At embolization procedure, an average of 1 week