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NCT02935088 · ClinicalTrials.gov registry record
PRESSUREwire Study
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 2,217
- Enrollment target
NCT02935088: Completed study, sponsored by Abbott Medical Devices.
NCT02935088 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 2,217 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02935088 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 2,217 participants
- Enrollment target
Study Summary
The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.
Primary Outcome
Major adverse cardiac events (MACE) is defined as a 12-month composite, including all cause death, documented non-fatal myocardial infarction, and unplanned hospitalization leading to urgent revascularization. Fisher Exact test will be performed to evaluate the association between 12-month MACE event and binary FFR variables respectively using the following FFR; Low FFR group (FFR ≤ 0.8) and high FFR group (FFR \> 0.8).
Interventions
- DEVICE Fractional Flow Reserve
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,217 participants |
| Start Date | 2016-10-12 |
| Est. Completion | 2019-03-22 |
What the finished NCT02935088 record still lists
NCT02935088 is an observational study that tracks outcomes without assigning an intervention. Its 2,217 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Fractional Flow Reserve is the first listed.
NCT02935088 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02935088 about?
NCT02935088 is a clinical study titled "PRESSUREwire Study". The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting wi...
What is the current status of trial NCT02935088?
This trial is currently completed. The enrollment target is 2,217 participants. The study started on 2016-10-12. Estimated completion is 2019-03-22.
What interventions are being tested in trial NCT02935088?
The interventions under investigation include: Fractional Flow Reserve (DEVICE).
Who is sponsoring clinical trial NCT02935088?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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