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

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ClinicalTrials.gov Identifier: NCT03853070
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
ClinSearch
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Aneurysm Arteriovenous Malformations Arterio-venous Fistula Device: ED Coil / Electro-detach Generator v4

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4
Actual Study Start Date : December 11, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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)

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853070


Locations
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Belgium
UZA Atwerp Not yet recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Voormolen    038214848    Maurits.Voormolen@uza.be   
Principal Investigator: Maurits Voormolen         
Germany
Knappschaftskrankenhaus Bochum Recruiting
Bochum, Nordrhein-Westfalen, Germany, 44892
Contact: Fischer    02342993801    sebastian.fischer@kk-bochum.de   
Principal Investigator: Sebastian Fischer         
Principal Investigator: Werner Weber         
Universitätsklinikum Schleswig-Holstein Recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Contact: Schramm    045150017215    Ramona.Schramm@uksh.de   
Principal Investigator: Peter Schramm         
Sponsors and Collaborators
Kaneka Corporation
ClinSearch

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Responsible Party: Kaneka Corporation
ClinicalTrials.gov Identifier: NCT03853070     History of Changes
Other Study ID Numbers: ED Coil Prosp
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vascular Malformations
Aneurysm
Fistula
Congenital Abnormalities
Arteriovenous Malformations
Hemangioma
Arteriovenous Fistula
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiovascular Abnormalities
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Vascular Fistula