Arteriovenous Dural Fistula
Conditions
Keywords
Fistula, Intracranial, Dural, Arteriovenous, Liquid Embolic
Brief summary
This study is a prospective, multicenter, single-arm study. Patients with Dural Arteriovenous Fistulas (dAVF) have a few choice for safe treatment. In this study, all patients with qualifying dAVFs will be treated with PHIL® Liquid Embolic material.
Interventions
DEVICEPHIL® Liquid Embolic System
The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)
Sponsors
Microvention-Terumo, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 22 - 80 years. * Subject is willing and capable of complying with all study protocol requirements, including specified follow-up period. * Subject or authorized legal representative must provide written informed consent prior to initiation of any study procedures. * Subject has an intracranial dAVF
Exclusion criteria
* Subject having multiple dAVFs to be treated. * Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated). * Subject has known allergies to dimethylsulfoxide, iodine. * Subject is currently participating in another clinical study * Female subject is currently pregnant. * Subject has co-morbid conditions that may limit survival to less than 24 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With Neurological Death or Ipsilateral Stroke | 30 days | Reported incidences of death or ipsilateral stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Events During the PHIL Embolization Procedure(s) | During the procedure | Reported incidences of technical events with PHIL device |
| Device-related Adverse Events | 30 days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| dAVF Treatment PHIL® Liquid Embolic System
PHIL® Liquid Embolic System: The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF) | 62 |
| Total | 62 |
Baseline characteristics
| Characteristic | dAVF Treatment |
|---|---|
| Age, Customized Age | 56.6 years STANDARD_DEVIATION 13.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment United States | 62 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 62 |
| other Total, other adverse events | 27 / 62 |
| serious Total, serious adverse events | 5 / 62 |
Outcome results
Primary
Subjects With Neurological Death or Ipsilateral Stroke
Reported incidences of death or ipsilateral stroke
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| dAVF Treatment | Subjects With Neurological Death or Ipsilateral Stroke | 0 Participants |
Secondary
Device-related Adverse Events
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| dAVF Treatment | Device-related Adverse Events | 1 Participants |
Secondary
Technical Events During the PHIL Embolization Procedure(s)
Reported incidences of technical events with PHIL device
Time frame: During the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| dAVF Treatment | Technical Events During the PHIL Embolization Procedure(s) | 0 Participants |