PHIL Evaluation in the Endovascular Treatment of Intracranial Cerebral ArterioVenous Malformation (cAVM)

NCT03341039 | Terminated

• 1 other identifier: cAVM-PHIL Registry
• Study Type: observational
• Target: 20
• Locations: 5 countries
• Sites: 16

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.

Conditions

Cerebral AV Malformation

Outcome Measures

Primary Outcomes (7)

• Overall cure rate

  immediately after final embolization

• Cure rate with regard to the aim of the endovascular treatment

  immediately after final embolization

• Overall cure rate

  3-6 months

• Cure rate with regard to the aim of the endovascular treatment

  3-6 months

• Clinical outcome compared to baseline

  Assessment by mRS

  up to 3 days

• Clinical outcome compared to baseline

  Assessment by mRS

  1 month after each embolization

• Clinical outcome compared to baseline

  Assessment by mRS

  3-6 months after the final embolization

Secondary Outcomes (7)

• Adverse Events

  1 months after last embolization

• Total volume of injected PHIL

  during each embolization

• Volume/superselective injection

  during each embolization

• Length of reflux of PHIL

  during each embolization

• Amount of pedicles catheterized

  during each embolization

Eligibility Criteria

• Age: 28 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead
• ClinSearch: collaborator

Study Sites (16)

Rigshospitalet University

Copenhagen, 2100, Denmark

Location

CHU Pellgrin

Bordeaux, 33000, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

CHU Limoges

Limoges, 87000, France

Location

La Fondation Rothschild

Paris, 75010, France

Location

Hôpital Pierre Paul Riquet

Toulouse, 31059, France

Location

Hospital Universitario General de Catalunya

Barcelona, 08190, Spain

Location

Hospital Nuestra Senora del Rosario

Madrid, 28006, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, 29010, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Universitetssjukhus Umea

Umeå, 90746, Sweden

Location

Uppsala University

Uppsala, 75185, Sweden

Location

University Hospital Birmingham

Birmingham, B15 2TH, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Charing Cross Hospital

London, W 8RF, United Kingdom

Location

MeSH Terms

Conditions

Intracranial Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Intracranial Arterial Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: November 14, 2017
• Study Start: November 14, 2017
• Primary Completion: October 14, 2020
• Study Completion: October 14, 2020
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2); DK (1); GB (3); ES (5); FR (5)