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NCT03115580 · ClinicalTrials.gov registry record · NA
Side Branch FFR After Provisional Stenting
A NA study of Coronary Artery Disease, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 71
- Enrollment target
- 1
- Study location
NCT03115580: Completed NA study of Coronary Artery Disease, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03115580 is a NA study of Coronary Artery Disease that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 71 participants, below the 1,287-participant average among 219 other Coronary Artery Disease 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
NCT03115580, a NA study of Coronary Artery Disease, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 71 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to predict any changes in the side branch after stenting the main branch blood vessel using three dimensional intravascular images. (Frequency domain optical coherence tomography FD OCT). Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture high-resolution, three-dimensional images of blood vessels. These images will be used before and after implanting the stent in the main blood vessel. Fractional Flow Reserve (FFR) test, which makes it possible for the interventional cardiologist to calculate blood flow across an area of a coronary artery, will be done after stenting and will help to determine if there are any changes in the side branch blood flow.
Primary Outcome
Number of participants with Side Branch (SB) compromise which is defined as SB DS \> 70%, or dissection or TIMI \< 3
Conditions Studied
Interventions
- DEVICE Rotational atherectomy
- DEVICE Cutting Balloon Angioplasty
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2017-05-02 |
| Est. Completion | 2019-03-26 |
| Phase | NA |
What the finished NCT03115580 record still lists
NCT03115580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Rotational atherectomy is the first listed.
NCT03115580 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03115580 about?
NCT03115580 is a clinical study titled "Side Branch FFR After Provisional Stenting". The purpose of this study is to predict any changes in the side branch after stenting the main branch blood vessel using three dimensional intravascular images. (Frequency domain optical coherence tomography FD OCT). Optical coherence tomography (OCT) is an established medical imaging technique tha...
What is the current status of trial NCT03115580?
This trial is currently completed. It is a NA study. The enrollment target is 71 participants. The study started on 2017-05-02. Estimated completion is 2019-03-26.
What conditions does trial NCT03115580 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT03115580?
The interventions under investigation include: Rotational atherectomy (DEVICE), Cutting Balloon Angioplasty (DEVICE).
Who is sponsoring clinical trial NCT03115580?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03115580 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
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Where NCT03115580's enrollment target sits among peer trials
71 164th of 219 higher than 56 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease 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.
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