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

February 21, 2019 updated by: Kaneka Corporation
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • Not yet recruiting
        • UZA Atwerp
        • Contact:
        • Principal Investigator:
          • Maurits Voormolen
  • Germany
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44892
        • Recruiting
        • Knappschaftskrankenhaus Bochum
        • Principal Investigator:
          • Sebastian Fischer
        • Contact:
        • Principal Investigator:
          • Werner Weber
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein
        • Contact:
        • Principal Investigator:
          • Peter Schramm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance Measure
Time Frame: 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
At 6 months
Performance Measure
Time Frame: 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
At 12 months
Safety Measure - Assessment of Adverse Events
Time Frame: During 12 months
All adverse events will be recorded, along with their seriousness and relatedness to the device or the procedure.
During 12 months
Technical Measure
Time Frame: 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)
At embolization procedure, an average of 1 week
Technical Measure
Time Frame: 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
At embolization procedure, an average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaneka Corporation

Collaborators

ClinSearch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 21, 2019

First Posted (Actual)

February 25, 2019

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ED Coil Prosp

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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