Subjects With Neurological Death or Ipsilateral Stroke
Primary
· 30 days
Reported incidences of death or ipsilateral stroke
| Group | Value | 95% CI |
|---|---|---|
| dAVF Treatment | 0 |
Last reviewed · How we verify
NCT03467542: PHIL dAVF
PHIL in the Treatment of Intracranial dAVF.
Completed
NA
Results posted
Last updated 31 December 2024
What this trial tests
NA trial testing PHIL® Liquid Embolic System in Arteriovenous Dural Fistula in 64 participants. Completed in 12 December 2022.
Timeline
24 August 2018
Primary endpoint
12 December 2022
12 December 2022
12 December 2022
Quick facts
| Lead sponsor | Microvention-Terumo, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 24 August 2018 |
| Primary completion | 12 December 2022 |
| Estimated completion | 12 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PHIL® Liquid Embolic System
Conditions studied
- Arteriovenous Dural Fistula — all drugs for Arteriovenous Dural Fistula →
Sponsor
Microvention-Terumo, Inc. — full company profile →
Who can join
Adults 22 to 80, any sex, with Arteriovenous Dural Fistula. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Technical Events During the PHIL Embolization Procedure(s)
Secondary
· During the procedure
Reported incidences of technical events with PHIL device
| Group | Value | 95% CI |
|---|---|---|
| dAVF Treatment | 0 |
Device-related Adverse Events
Secondary
· 30 days
| Group | Value | 95% CI |
|---|---|---|
| dAVF Treatment | 1 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 months after last embolization. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
dAVF Treatment
Serious: 5/62 (8%)
Deaths: 1/62
Serious adverse events (7 terms)
| Reaction | System | dAVF Treatment |
|---|---|---|
| Acute myocardial infarction | Cardiac disorders | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Head injury | Injury, poisoning and procedural complications | — |
| Failure to thrive | Metabolism and nutrition disorders | — |
| Seizure | Nervous system disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Aortic dissection | Vascular disorders | — |
Other adverse events (31 terms — click to expand)
| Reaction | System | dAVF Treatment |
|---|---|---|
| Headache | Nervous system disorders | — |
| Radiation alopecia | Injury, poisoning and procedural complications | — |
| Procedural headache | Nervous system disorders | — |
| Procedural nausea | Injury, poisoning and procedural complications | — |
| Seizure | Nervous system disorders | — |
| dysacusis | Ear and labyrinth disorders | — |
| Tinnitus | Ear and labyrinth disorders | — |
| Diplopia | Eye disorders | — |
| Visual acuity reduced | Eye disorders | — |
| Visual impairment | Eye disorders | — |
| Swelling face | General disorders | — |
| Ear infection | Infections and infestations | — |
| Vascular site access hematoma | Injury, poisoning and procedural complications | — |
| Urinary retention post operative | Injury, poisoning and procedural complications | — |
| Vascular access site pseudo aneurysm | Injury, poisoning and procedural complications | — |
| Urinary tract procedural complication | Injury, poisoning and procedural complications | — |
| Vascular access site pain | Injury, poisoning and procedural complications | — |
| Procedural headache | Injury, poisoning and procedural complications | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — |
| Transient Ischemic Attack | Nervous system disorders | — |
| Paraesthesia | Nervous system disorders | — |
| Facial paralysis | Nervous system disorders | — |
| Failure to thrive | Metabolism and nutrition disorders | — |
| Ischemic stroke | Nervous system disorders | — |
| Cerebral vasoconstriction | Nervous system disorders | — |
| Facial paresis | Nervous system disorders | — |
| Hemiparesis | Nervous system disorders | — |
| Papillo edema | Nervous system disorders | — |
| Syncope | Nervous system disorders | — |
| dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Hypertension | Vascular disorders | — |
Most-reported serious reactions: Acute myocardial infarction, Upper respiratory tract infection, Head injury, Failure to thrive, Seizure, Acute kidney injury, Aortic dissection.
Data from ClinicalTrials.gov NCT03467542 adverse events section.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03467542
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Microvention-Terumo, Inc. trials
Trials by the same sponsor.
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- NCT04999423 — LVIS™ Evo™ and HydroCoil® Embolic System for Intracranial Aneurysm Treatment · active not recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03467542 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Microvention-Terumo, Inc.
- Last refreshed: 31 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03467542.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing