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Prospective Study to Assess the Safety and Performance of the Easyx Antia Liquid Embolic in Intracranial Interventions (Ideale)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02863133
Recruitment Status : Unknown
Verified August 2016 by Antia Therapeutics AG.
Recruitment status was:  Not yet recruiting
First Posted : August 11, 2016
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Antia Therapeutics AG

Brief Summary:
The study is a prospective, multicenter, multinational study to assess the safety and performance of the Easyx (trade name) Antia Liquid Embolic during embolization of intracranial malformations and fistulas. The clinical trial will include patients already scheduled for neuroradiological interventions. It is estimated that up to 8 sites will be required to collect the safety and performance data of the study material. Up to 65 patients will be enrolled in the study to achieve 53 evaluable patients. Each study centre will be required to treat 5 patients with a Dural arteriovenous fistula - DAVF before they can treat brain arteriovenous malformations - AVMs or brain tumours. Only experienced neuroradiologists will be invited to participate in this study.

Condition or disease Intervention/treatment Phase
Arterial Embolization Device: Liquid Embolic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Multicenter, Multinational Study to Assess the Safety and Performance of the Easyx Antia Liquid Embolic in Intracranial Interventions IDEALE Study
Study Start Date : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: Easyx Liquid Embolic
embolization of intracranial malformations and fistulas and brain tumours with Easyx Liquid Embolic
Device: Liquid Embolic
The Easyx liquid embolic, manufactured by Antia AG, is intended to occlude hypervascular lesions in the brain such as tumors, arteriovenous malformations (a tangle of abnormal and poorly formed blood vessels) and dural arteriovenous fistulas (abnormal connection of blood vessels).
Other Name: Easyx




Primary Outcome Measures :
  1. Device related adverse events [ Time Frame: 1 month ]
    The incidence of adverse events related to the device and procedure at 1 month follow up to ensure that the rate is equivalent to other products already on the market.

  2. Technical Success [ Time Frame: immediate ]
    The primary technical success endpoint is measured by evaluating the percentage achieved obliteration degree of the DAVF vascular lesion target or planned AVM region or vascular supply to a tumor. The assessment is done by means of a questionnaire


Secondary Outcome Measures :
  1. Status of the lesion [ Time Frame: 3 and 6 months ]
    Comparison of Cognard score (I, IIa, IIb, III, IV, V) for DAVFs and Spetzler Martin Grade (0, I, II, III, IV, V) for BAVMs pre and post treatment and at 3-6 months.The measures will be recorded in tables identifying and separating the scores

  2. Useability [ Time Frame: immediate ]
    Analysis of usability by a procedure questionnaire on the handling of the Easyx product

  3. Neurological changes [ Time Frame: 1, 6 and12 months ]
    A qualitative assessment if neurological changes appears at 1 month, 6 months and 12 months. If yes the changes will be itemized and described individually in a table



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

Inclusion Criteria:

  1. Subject is aged 18 years or over
  2. Subject exhibits a DAVF or BAVM or tumor that has been selected for endovascular treatment
  3. Subject has provided written consent for the procedure.
  4. Subject agrees to all follow up visits required by the protocol
  5. The Subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization.

Exclusion Criteria:

  1. The subject has a brain AVM with high flow arteriovenous fistula that the investigator has determined to be unsuitable for embolization.
  2. The subject has had acute cerebral bleeding within the last 6 months.
  3. The patient is participating in another research study involving another investigational device, procedure or drug.
  4. The brain AVM or DAVF or tumor has been previously treated with another embolization agent.
  5. The subject has a bleeding disorder.
  6. The subject is female and has a positive pregnancy test.
  7. The subject has a life expectancy of less than 1 year.
  8. Subject has a known allergy to contrast media used for radiography.
  9. Subject has a known allergy to Dimethyl Sulfoxide - DMSO (solvent for the embolic product).
  10. Subject has a condition that would prevent them attending follow up visits for up to 1 year.

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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): NCT02863133


Contacts
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Contact: Gert Andersen, B Sc +4523600650 Gert.Andersen@antia.ch
Contact: Olivier Jordan, Doctor Phd +41223796586 olivier.jordan@antia.ch

Sponsors and Collaborators
Antia Therapeutics AG

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Responsible Party: Antia Therapeutics AG
ClinicalTrials.gov Identifier: NCT02863133    
Other Study ID Numbers: 028
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided