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

NCT03853070 | Unknown

• 1 other identifier: ED Coil Prosp
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 3

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.

Conditions

Aneurysm; Arteriovenous Malformations; Arterio-venous Fistula

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Interventions

ED Coil / Electro-detach Generator v4 DEVICE

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with an aneurysm, arteriovenous malformation, or arteriovenous fistula and eligible for endovascular treatment with ED Coil and ED Detach Generator v4.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kaneka Corporation: lead
• ClinSearch: collaborator

Study Sites (3)

UZA Atwerp

Edegem, Antwerp, 2650, Belgium

NOT YET RECRUITING

Knappschaftskrankenhaus Bochum

Bochum, North Rhine-Westphalia, 44892, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

MeSH Terms

Conditions

Aneurysm; Arteriovenous Malformations; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vascular Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 25, 2019
• Study Start: December 11, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2021
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

DE (2); BE (1)