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NCT03731000 · ClinicalTrials.gov registry record · NA
PHIL® Embolic System Pediatric IDE
A NA study of Arteriovenous Fistula and Intracranial Arteriovenous Malformations, sponsored by Alejandro Berenstein.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT03731000: Recruiting NA study of Arteriovenous Fistula and Intracranial Arteriovenous Malformations, sponsored by Alejandro Berenstein.
NCT03731000 is a NA study of Arteriovenous Fistula and Intracranial Arteriovenous Malformations that is actively recruiting participants, run by Alejandro Berenstein. The registered enrollment target is 15 participants, below the 231-participant average among 8 other Arteriovenous Fistula trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03731000, a NA study of Arteriovenous Fistula and Intracranial Arteriovenous Malformations, is actively recruiting participants, sponsored by Alejandro Berenstein.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to collect information about how the PHIL® Embolic System works in the treatment of intracranial dural arteriovenous fistulas. Data collected in this study will be used to evaluate the safety and probable benefits in treating DAVFs. The PHIL® Embolic System is a Humanitarian Use Device (HUD). The U.S. Food and Drug Administration (FDA) approved the use of the PHIL Embolic System as a HUD in June 2016.
Primary Outcome
The proportion of subjects with neurological death or major ipsilateral stroke (defined as a major stroke within the vascular distribution of the vessel targeted for treatment) within 12 months following completion of treatment, reported as one composite data variable
Conditions Studied
Interventions
- DEVICE PHIL® device
Study Locations (1)
New York
- Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-04-16 |
| Est. Completion | 2027-12 |
| Phase | NA |
What NCT03731000 shows while recruiting
NCT03731000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 231-participant average among 8 other Arteriovenous Fistula trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Arteriovenous Fistula appearing as the primary indexed condition, and to 1 intervention - of which PHIL® device is the first listed.
NCT03731000 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03731000 about?
NCT03731000 is a clinical study titled "PHIL® Embolic System Pediatric IDE". The purpose of this study is to collect information about how the PHIL® Embolic System works in the treatment of intracranial dural arteriovenous fistulas. Data collected in this study will be used to evaluate the safety and probable benefits in treating DAVFs. The PHIL® Embolic System is a Humanit...
What is the current status of trial NCT03731000?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2019-04-16. Estimated completion is 2027-12.
What conditions does trial NCT03731000 study?
This clinical trial studies the following conditions: Arteriovenous Fistula, Intracranial Arteriovenous Malformations.
What interventions are being tested in trial NCT03731000?
The interventions under investigation include: PHIL® device (DEVICE).
Who is sponsoring clinical trial NCT03731000?
This trial is sponsored by Alejandro Berenstein, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03731000 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Arteriovenous Fistula
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03731000's enrollment target sits among peer trials
15 9th of 8 the lowest of 8 other Arteriovenous Fistula trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arteriovenous Fistula trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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