Trial Outcomes & Findings for PHIL in the Treatment of Intracranial dAVF. (NCT NCT03467542)

NCT ID: NCT03467542

Last Updated: 2024-12-31

Results Overview

Reported incidences of death or ipsilateral stroke

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 64 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2024-12-31

Participant Flow

Participant milestones

Measure	dAVF Treatment PHIL® Liquid Embolic System PHIL® Liquid Embolic System: The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)
Overall Study STARTED	62
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PHIL in the Treatment of Intracranial dAVF.

Baseline characteristics by cohort

Measure	dAVF Treatment n=62 Participants PHIL® Liquid Embolic System PHIL® Liquid Embolic System: The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)
Age, Customized Age	56.6 years STANDARD_DEVIATION 13.31 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Reported incidences of death or ipsilateral stroke

Outcome measures

Measure	dAVF Treatment n=62 Participants PHIL® Liquid Embolic System PHIL® Liquid Embolic System: The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)
Subjects With Neurological Death or Ipsilateral Stroke	0 Participants

SECONDARY outcome

Timeframe: During the procedure

Reported incidences of technical events with PHIL device

Outcome measures

Measure	dAVF Treatment n=62 Participants PHIL® Liquid Embolic System PHIL® Liquid Embolic System: The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)
Technical Events During the PHIL Embolization Procedure(s)	0 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	dAVF Treatment n=62 Participants PHIL® Liquid Embolic System PHIL® Liquid Embolic System: The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)
Device-related Adverse Events	1 Participants

Adverse Events

dAVF Treatment

Serious events: 5 serious events

Other events: 27 other events

Deaths: 1 deaths

Serious adverse events

Measure	dAVF Treatment n=62 participants at risk PHIL® Liquid Embolic System PHIL® Liquid Embolic System: The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)
Cardiac disorders Acute myocardial infarction	1.6% 1/62 • 6 months after last embolization
Infections and infestations Upper respiratory tract infection	1.6% 1/62 • 6 months after last embolization
Injury, poisoning and procedural complications Head injury	1.6% 1/62 • 6 months after last embolization
Metabolism and nutrition disorders Failure to thrive	1.6% 1/62 • 6 months after last embolization
Nervous system disorders Seizure	1.6% 1/62 • 6 months after last embolization
Renal and urinary disorders Acute kidney injury	1.6% 1/62 • 6 months after last embolization
Vascular disorders Aortic dissection	1.6% 1/62 • 6 months after last embolization

Other adverse events

Measure	dAVF Treatment n=62 participants at risk PHIL® Liquid Embolic System PHIL® Liquid Embolic System: The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)
Ear and labyrinth disorders dysacusis	1.6% 1/62 • 6 months after last embolization
Ear and labyrinth disorders Tinnitus	1.6% 1/62 • 6 months after last embolization
Eye disorders Diplopia	1.6% 1/62 • 6 months after last embolization
Eye disorders Visual acuity reduced	1.6% 1/62 • 6 months after last embolization
Eye disorders Visual impairment	1.6% 1/62 • 6 months after last embolization
General disorders Swelling face	1.6% 1/62 • 6 months after last embolization
Infections and infestations Ear infection	1.6% 1/62 • 6 months after last embolization
Injury, poisoning and procedural complications Radiation alopecia	6.5% 4/62 • 6 months after last embolization
Injury, poisoning and procedural complications Procedural nausea	3.2% 2/62 • 6 months after last embolization
Injury, poisoning and procedural complications Vascular site access hematoma	1.6% 1/62 • 6 months after last embolization
Injury, poisoning and procedural complications Urinary retention post operative	1.6% 1/62 • 6 months after last embolization
Injury, poisoning and procedural complications Vascular access site pseudo aneurysm	1.6% 1/62 • 6 months after last embolization
Injury, poisoning and procedural complications Urinary tract procedural complication	1.6% 1/62 • 6 months after last embolization
Injury, poisoning and procedural complications Vascular access site pain	1.6% 1/62 • 6 months after last embolization
Injury, poisoning and procedural complications Procedural headache	1.6% 1/62 • 6 months after last embolization
Musculoskeletal and connective tissue disorders Neck pain	1.6% 1/62 • 6 months after last embolization
Nervous system disorders Headache	9.7% 6/62 • 6 months after last embolization
Nervous system disorders Procedural headache	4.8% 3/62 • 6 months after last embolization
Nervous system disorders Seizure	3.2% 2/62 • 6 months after last embolization
Nervous system disorders Transient Ischemic Attack	1.6% 1/62 • 6 months after last embolization
Nervous system disorders Paraesthesia	1.6% 1/62 • 6 months after last embolization
Nervous system disorders Facial paralysis	1.6% 1/62 • 6 months after last embolization
Metabolism and nutrition disorders Failure to thrive	1.6% 1/62 • 6 months after last embolization
Nervous system disorders Ischemic stroke	1.6% 1/62 • 6 months after last embolization
Nervous system disorders Cerebral vasoconstriction	1.6% 1/62 • 6 months after last embolization
Nervous system disorders Facial paresis	1.6% 1/62 • 6 months after last embolization
Nervous system disorders Hemiparesis	1.6% 1/62 • 6 months after last embolization
Nervous system disorders Papillo edema	1.6% 1/62 • 6 months after last embolization
Nervous system disorders Syncope	1.6% 1/62 • 6 months after last embolization
Respiratory, thoracic and mediastinal disorders dyspnoea	1.6% 1/62 • 6 months after last embolization
Vascular disorders Hypertension	1.6% 1/62 • 6 months after last embolization

Additional Information

Robert Gash

Terumo Neuro

Phone: 714-247-8000

Email: robert.gash@microvention.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Principal Investigator may publish the results if Sponsor has not published within eighteen (18) months after FDA approval of the Trial Devices. The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER