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

NCT02863133 | Unknown

• 1 other identifier: 028
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arterial Embolization

Outcome Measures

Primary Outcomes (2)

• Device related adverse events

  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.

  1 month

• Technical Success

  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

  immediate

Secondary Outcomes (3)

• Status of the lesion

  3 and 6 months

• Useability

  immediate

• Neurological changes

  1, 6 and12 months

Study Arms (1)

Easyx Liquid Embolic

EXPERIMENTAL

embolization of intracranial malformations and fistulas and brain tumours with Easyx Liquid Embolic

Device: Liquid Embolic

Interventions

Liquid Embolic DEVICE

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).

Also known as: Easyx

Easyx Liquid Embolic

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Antia Therapeutics AG: lead

Central Study Contacts

Gert Andersen, B Sc

CONTACT

+4523600650; Gert.Andersen@antia.ch

Olivier Jordan, Doctor Phd

CONTACT

+41223796586; olivier.jordan@antia.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 11, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: August 11, 2016

Record last verified: 2016-08