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NCT02648230 · ClinicalTrials.gov registry record · NA
PrEssure wiRe Compared to Microcatheter-based Sensing Technology For the Evaluation of FFR Measurements
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 74
- Enrollment target
NCT02648230: Completed NA study, sponsored by Columbia University.
NCT02648230 is a NA study that has completed, run by Columbia University. The registered enrollment target is 74 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02648230, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 74 participants
- Enrollment target
Study Summary
The model by which physicians measure the lack of blood flow in the vessels that supply blood to the heart muscle is called Fractional Flow Reserve (FFR). FFR is the measurement of the pressure across the vessels that supply blood to the heart. These are known as the coronary arteries. This study involves comparing two FFR wires, the St. Jude Medical Pressure Wire (PW) and the ACIST Navvus Microcatheter (MC) to check the accuracy of the devices. FFR allows real-time estimation of the effects of a narrowed vessel, whereas standard angiography can underestimate or overestimate narrowing, because it only visualizes contrast (the different areas of color) inside a vessel.
Primary Outcome
The mean FFR will be measured with the pressure catheter (PC) to be compared against the mean FFR measured with a standard Pressure Wire (PW) within the same subject across the same target lesion at the same time. Fractional flow reserve measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery.
Interventions
- DEVICE St. Jude Medical Pressure Wire
- DEVICE ACIST Navvus Microcatheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-12-08 |
| Phase | NA |
What the finished NCT02648230 record still lists
NCT02648230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which St. Jude Medical Pressure Wire is the first listed.
NCT02648230 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02648230 about?
NCT02648230 is a clinical study titled "PrEssure wiRe Compared to Microcatheter-based Sensing Technology For the Evaluation of FFR Measurements". The model by which physicians measure the lack of blood flow in the vessels that supply blood to the heart muscle is called Fractional Flow Reserve (FFR). FFR is the measurement of the pressure across the vessels that supply blood to the heart. These are known as the coronary arteries. This study in...
What is the current status of trial NCT02648230?
This trial is currently completed. It is a NA study. The enrollment target is 74 participants. The study started on 2015-12. Estimated completion is 2016-12-08.
What interventions are being tested in trial NCT02648230?
The interventions under investigation include: St. Jude Medical Pressure Wire (DEVICE), ACIST Navvus Microcatheter (DEVICE).
Who is sponsoring clinical trial NCT02648230?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02648230's enrollment target sits among peer trials
74 1082nd of 2000 higher than 912 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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