Prospective Study to Assess the Safety and Performance of the Easyx Antia Liquid Embolic in Intracranial Interventions (Ideale)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Arterial Embolization||Device: Liquid Embolic||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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
- 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
- Useability [ Time Frame: immediate ]Analysis of usability by a procedure questionnaire on the handling of the Easyx product
- 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
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
|Contact: Gert Andersen, B Sc||+4523600650||Gert.Andersen@antia.ch|
|Contact: Olivier Jordan, Doctor Phdemail@example.com|