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NCT04019535 · ClinicalTrials.gov registry record
Diastolic Hyperemia Free Index for Assessment of Moderate Coronary Stenoses
A clinical trial, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- 88
- Enrollment target
NCT04019535: Completed study, sponsored by Washington University School of Medicine.
NCT04019535 is a clinical trial that has completed, run by Washington University School of Medicine. The registered enrollment target is 88 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04019535 has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- 88 participants
- Enrollment target
Study Summary
A total of 106 subjects will be enrolled at up to 3 sites. Initial enrollment will occur at Washington University only. After 15 subjects have been enrolled at the primary site and no serious adverse events or protocol events have occurred the additional sites will be trained and added to enrollment.
Primary Outcome
. DFR will be correlated, in VIVO, with the gold standard, diastolic coronary blood flow measurement, the instantaneous wave free ratio (iFR). Both DFR and iFR will be correlated simultaneously during the index procedure in patients with moderate coronary stenoses whom hemodynamic assessment was clinically indicated.
Interventions
- DEVICE physiological assessment with Volcano Verrata pressure wire (iFR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2019-08-22 |
| Est. Completion | 2023-12-31 |
What the finished NCT04019535 record still lists
NCT04019535 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 88 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which physiological assessment with Volcano Verrata pressure wire (iFR) is the first listed.
NCT04019535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04019535 about?
NCT04019535 is a clinical study titled "Diastolic Hyperemia Free Index for Assessment of Moderate Coronary Stenoses". A total of 106 subjects will be enrolled at up to 3 sites. Initial enrollment will occur at Washington University only. After 15 subjects have been enrolled at the primary site and no serious adverse events or protocol events have occurred the additional sites will be trained and added to enrollment...
What is the current status of trial NCT04019535?
This trial is currently completed. The enrollment target is 88 participants. The study started on 2019-08-22. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT04019535?
The interventions under investigation include: physiological assessment with Volcano Verrata pressure wire (iFR) (DEVICE).
Who is sponsoring clinical trial NCT04019535?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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