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NCT03663257 · ClinicalTrials.gov registry record
Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
A clinical trial, sponsored by Philips Clinical & Medical Affairs Global.
- Completed
- Registry status
- 132
- Enrollment target
NCT03663257: Completed study, sponsored by Philips Clinical & Medical Affairs Global.
NCT03663257 is a clinical trial that has completed, run by Philips Clinical & Medical Affairs Global. The registered enrollment target is 132 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03663257 has completed, sponsored by Philips Clinical & Medical Affairs Global.
- COMPLETED
- Registry status
- 132 participants
- Enrollment target
Study Summary
AneurysmFlow R1.0 is an approved (i.e. CE labeled, 510k, Health Canada), software tool intended to provide relevant information on the blood flow in a cerebral aneurysm and its parent artery based on angiography. It calculates the Mean Aneurysm Flow Amplitude (MAFA) ratio to measure the volumetric flow rate quotient before and after Flow Diverter Stent (FDS) implantation in the region of interest. The current study is a prospective, single arm, observational, multicenter cohort study to assess the prognostic value of the MAFA ratio for predicting full aneurysm occlusion 12 months after flow diverter placement.
Primary Outcome
To assess the prognostic value (i.e. c-statistic including confidence intervals) of the MAFA ratio with respect to full aneurysm occlusion (i.e. using the Raymond-Roy Occlusion Classification I on standard-of-care head imaging) 12 months after Flow Diverter Stent placement. The objective was evaluated using logistic regression analysis to evaluate the univariate predictive association between the index test (i.e., the MAFA ratio) and complete aneurysm occlusion (i.e., complete occlusion yes/no)
Interventions
- DEVICE AneurysmFlow
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2018-10-04 |
| Est. Completion | 2023-11-27 |
What the finished NCT03663257 record still lists
NCT03663257 is an observational study that tracks outcomes without assigning an intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which AneurysmFlow is the first listed.
NCT03663257 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03663257 about?
NCT03663257 is a clinical study titled "Study to Evaluate Cerebral AneurysmFlow Results in Occlusion". AneurysmFlow R1.0 is an approved (i.e. CE labeled, 510k, Health Canada), software tool intended to provide relevant information on the blood flow in a cerebral aneurysm and its parent artery based on angiography. It calculates the Mean Aneurysm Flow Amplitude (MAFA) ratio to measure the volumetric f...
What is the current status of trial NCT03663257?
This trial is currently completed. The enrollment target is 132 participants. The study started on 2018-10-04. Estimated completion is 2023-11-27.
What interventions are being tested in trial NCT03663257?
The interventions under investigation include: AneurysmFlow (DEVICE).
Who is sponsoring clinical trial NCT03663257?
This trial is sponsored by Philips Clinical & Medical Affairs Global, which has 45 total clinical trials registered on ClinicalTrials.gov.
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