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

Cerebral AV Malformation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03341039
• Other study ID #: cAVM-PHIL Registry
• Status: Terminated
• Start date: November 14, 2017
• Est. completion date: October 14, 2020

Study information

• Verified date: July 2021
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 14, 2020
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Cerebral AV Malformation
• Congenital Abnormalities
• Intracranial Arteriovenous Malformations

Locations

Country	Name	City	State
Denmark	Rigshospitalet University	Copenhagen
France	CHU Pellgrin	Bordeaux
France	Hôpital Bicêtre	Le Kremlin-Bicêtre
France	CHU Limoges	Limoges
France	La Fondation Rothschild	Paris
France	Hôpital Pierre Paul Riquet	Toulouse
Spain	Hospital Universitario General de Catalunya	Barcelona
Spain	Hospital Nuestra Senora del Rosario	Madrid
Spain	Hospital Regional Universitario Carlos Haya	Málaga
Spain	Hospital Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Sweden	Universitetssjukhus Umea	Umeå
Sweden	Uppsala University	Uppsala
United Kingdom	University Hospital Birmingham	Birmingham
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Charing Cross Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Microvention-Terumo, Inc.	ClinSearch

Countries where clinical trial is conducted

Denmark,  France,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall cure rate		immediately after final embolization
Primary	Cure rate with regard to the aim of the endovascular treatment		immediately after final embolization
Primary	Overall cure rate		3-6 months
Primary	Cure rate with regard to the aim of the endovascular treatment		3-6 months
Primary	Clinical outcome compared to baseline	Assessment by mRS	up to 3 days
Primary	Clinical outcome compared to baseline	Assessment by mRS	1 month after each embolization
Primary	Clinical outcome compared to baseline	Assessment by mRS	3-6 months after the final embolization
Secondary	Adverse Events	AE related to the PHIL procedure and/or to the techniques used during each embolization	1 months after last embolization
Secondary	Total volume of injected PHIL		during each embolization
Secondary	Volume/superselective injection		during each embolization
Secondary	Length of reflux of PHIL		during each embolization
Secondary	Amount of pedicles catheterized		during each embolization
Secondary	Overall injection time		during each embolization
Secondary	Overall radiation dose given to the patient during EVT		during each embolization