PHIL Evaluation in the Endovascular Treatment of Intracranial Cerebral ArterioVenous Malformation a European Multi-center, Observational, Prospective, Single Arm and Open Label Study
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Microvention-Terumo, Inc.
- Enrollment
- 20
- Locations
- 16
- Primary Endpoint
- Cure rate with regard to the aim of the endovascular treatment
Overview
Brief Summary
The primary objective of this study is to assess the efficacy and safety of PHIL® liquid embolic agent in endovascular embolization of cerebral arteriovenous malformations.
Detailed Description
This is an European multi-center observational study. Treatments and follow-up visits will be done as per standard of care.
The objective of this study is to evaluate the efficacy and safety of the PHIL® device in the treatment of intracranial cerebral arteriovenous malformation. The PHIL® device, a non-adhesive liquid embolic agent, has been CE marked since July 2014. It is intended for use in the embolization of lesions in the peripheral and neurovasculature, including arteriovenous malformations and hypervascular tumors.
All patients with a cAVM, ruptured or unruptured, eligible for endovascular treatment with a liquid embolic agent, PHIL®, based on multidisciplinary consensus are eligible for this study. A maximum of 108 patients will be enrolled in 18 European Institutions.
The expected approximate study duration is 39 months.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 28 Days to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients with a ruptured or unruptured and previously endovascularly untreated cAVM that are eligible for endovascular treatment with PHIL® alone or in conjunction with N-Butyl cyanoacrylate glue (NBCA) and/or coils (e.g. if "pressure cooking" technique is needed or used).
- •All patients with a previously endovascularly treated cAVM in which NBCA and/or coils (but not another non-adhesive liquid embolic agent) have been used may be included.\*\*
- •All patients with a remaining cAVM, ruptured or unruptured, that has previously been treated with NS and/or RT may be included.
- •Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form. (Based on the country's regulation).
Exclusion Criteria
- •cAVM not eligible for endovascular treatment
- •cAVM previously treated with a non-adhesive liquid embolic agent other than PHIL®
- •Treatment requiring the use of any other non-adhesive embolic liquid
- •Patient is allergic to iodine
- •Premature and newborn infant
- •Patient with renal failure or significant liver impairment
- •Patient is participating in another study evaluating other medical devices, other procedures or medications.
- •Any other condition that might prevent patient participation in the study or follow up
- •Patient does not want to and/or refuses to give consent to the collection and processing of data required for centralized monitoring
Outcomes
Primary Outcomes
Cure rate with regard to the aim of the endovascular treatment
Time Frame: 3-6 months
Clinical outcome compared to baseline
Time Frame: 3-6 months after the final embolization
Assessment by mRS
Overall cure rate
Time Frame: 3-6 months
Secondary Outcomes
- Overall radiation dose given to the patient during EVT(during each embolization)
- Overall injection time(during each embolization)
- Adverse Events(1 months after last embolization)
- Total volume of injected PHIL(during each embolization)
- Volume/superselective injection(during each embolization)
- Amount of pedicles catheterized(during each embolization)
- Length of reflux of PHIL(during each embolization)