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Termination of the study due to low enrolment
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| Name | Class |
|---|---|
| ClinSearch | OTHER |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | AE related to the PHIL procedure and/or to the techniques used during each embolization | 1 months after last embolization |
| Total volume of injected PHIL | during each embolization |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with a cAVM, ruptured or unruptured, eligible for endovascular treatment with a liquid embolic agent, PHIL®, based on multidisciplinary consensus.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet University | Copenhagen | 2100 | Denmark | |||
| CHU Pellgrin |
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| Volume/superselective injection | during each embolization |
| Length of reflux of PHIL | during each embolization |
| Amount of pedicles catheterized | during each embolization |
| Overall injection time | during each embolization |
| Overall radiation dose given to the patient during EVT | during each 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 | W 8RF | United Kingdom |
| ID | Term |
|---|---|
| D002538 | Intracranial Arteriovenous Malformations |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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