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| Name | Class |
|---|---|
| ClinSearch | OTHER |
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The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.
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 dural ArterioVenous Fistula (dAVF). 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 an intracranial dAVF that has not been previously treated and will be treated by embolization with PHIL® are eligible for this study. A maximum of 70 patients will be enrolled in this study in 16 European Institutions.
The expected approximate study duration is 38 months.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events and assessment of neurological status at 1 month after each embolization | Neurological assessment by mRS | 1 month |
| Assessment of cure rate and of clinical course of the patient (stable /improvement /deteriorated) | Cure rate assessment by Angiography | 3-6 months after last embolization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events and assessment of neurological status | Neurological assessment by mRS | 3-6 months after last embolization |
| Improvement in the quality of life of the patient and changes in patients symptoms |
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Inclusion Criteria:
Exclusion Criteria:
3. Any condition that could prevent patient follow up.
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Any patients having an untreated dural arteriovenous fistula requiring treatment will be screened by the investigational sites. Those eligible to be treated with PHIL® will be enrolled after having dated and signed an informed consent form as per appropriate regulation in the participating country.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet University | Copenhagen | 2100 | Denmark | |||
| CHU Pellgrin |
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| ID | Term |
|---|---|
| D020785 | Central Nervous System Vascular Malformations |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
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Assessed by Quality of Life Questionnaire EQ 5D
| 3-6 months after last embolization |
| Bordeaux |
| 33000 |
| France |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | 94270 | France |
| CHU Limoges | Limoges | 87000 | France |
| La Fondation Rothschild | Paris | 75010 | France |
| Hôpital Pierre Paul Riquet | Toulouse | 31059 | France |
| Hospital Universitario General de Catalunya | Barcelona | 08190 | Spain |
| Hospital Nuestra Senora del Rosario | Madrid | 28006 | Spain |
| Hospital Regional Universitario Carlos Haya | Málaga | 29010 | Spain |
| Hospital Universitario Virgen de la Arrixaca | Murcia | 30120 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Universitetssjukhus Umea | Umeå | 90746 | Sweden |
| Uppsala University | Uppsala | 75185 | Sweden |
| University Hospital Birmingham | Birmingham | B15 2TH | United Kingdom |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |