Clinical trial NCT03341039: PHIL Evaluation in the Endovascular Treatment of Intracranial Cerebral ArterioVenous Malformation (cAVM)
Official title: PHIL Evaluation in the Endovascular Treatment of Intracranial Cerebral ArterioVenous Malformation a European Multi-center, Observational, Prospective, Single Arm and Open Label Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebral AV Malformation
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ClinSearch
First posted: 2017-11-14
Enrollment: 20
Sex: ALL
Minimum age (years): 28
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a cAVM, ruptured or unruptured, eligible for endovascular treatment with a liquid embolic agent, PHIL®, based on multidisciplinary consensus.

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.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. 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.\*\*
3. All patients with a remaining cAVM, ruptured or unruptured, that has previously been treated with NS and/or RT may be included.
4. 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:

1. cAVM not eligible for endovascular treatment
2. cAVM previously treated with a non-adhesive liquid embolic agent other than PHIL®
3. Treatment requiring the use of any other non-adhesive embolic liquid
4. Patient is allergic to iodine
5. Premature and newborn infant
6. Patient with renal failure or significant liver impairment
7. Patient is participating in another study evaluating other medical devices, other procedures or medications.
8. Any other condition that might prevent patient participation in the study or follow up
9. Patient does not want to and/or refuses to give consent to the collection and processing of data required for centralized monitoring

Primary outcomes:
measure: Overall cure rate
timeFrame: immediately after final embolization
measure: Cure rate with regard to the aim of the endovascular treatment
timeFrame: immediately after final embolization
measure: Overall cure rate
timeFrame: 3-6 months
measure: Cure rate with regard to the aim of the endovascular treatment
timeFrame: 3-6 months
measure: Clinical outcome compared to baseline
timeFrame: up to 3 days
measure: Clinical outcome compared to baseline
timeFrame: 1 month after each embolization
measure: Clinical outcome compared to baseline
timeFrame: 3-6 months after the final embolization
Secondary outcomes:
measure: Adverse Events
timeFrame: 1 months after last embolization
measure: Total volume of injected PHIL
timeFrame: during each embolization
measure: Volume/superselective injection
timeFrame: during each embolization
measure: Length of reflux of PHIL
timeFrame: during each embolization
measure: Amount of pedicles catheterized
timeFrame: during each embolization
measure: Overall injection time
timeFrame: during each embolization
measure: Overall radiation dose given to the patient during EVT
timeFrame: during each embolization
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet University
city: Bordeaux
country: France
facility: CHU Pellgrin
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Limoges
country: France
facility: CHU Limoges
city: Paris
country: France
facility: La Fondation Rothschild
city: Toulouse
country: France
facility: Hôpital Pierre Paul Riquet
city: Barcelona
country: Spain
facility: Hospital Universitario General de Catalunya
city: Madrid
country: Spain
facility: Hospital Nuestra Senora del Rosario
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Umeå
country: Sweden
facility: Universitetssjukhus Umea
city: Uppsala
country: Sweden
facility: Uppsala University
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
References: