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NCT03557385 · ClinicalTrials.gov registry record · Phase 4
Adenosine Contrast CorrELations in Evaluating RevAscularizaTION
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 201
- Enrollment target
NCT03557385: Completed Phase 4 study, sponsored by Duke University.
NCT03557385 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 201 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03557385, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 201 participants
- Enrollment target
Study Summary
The purpose of this study is to compare FFR measurements done with adenosine to FFR measurements done with contrast, where the contrast is injected using the ACIST CVi automated contrast injector. The ACCELERATION study will support a safer approach to FFR for patients by potentially reducing toxic drug exposure (adenosine). The 2 main objectives of the study are: 1. Perform a methods comparison between cFFR and the reference standard aFFR, where cFFR is performed using an automated injector with a standardized volume and rate of delivery of contrast with known osmolality. 2. Evaluate the association between final post-PCI FFR and long-term clinical outcomes. The long-term clinical outcomes will include TVR and composite MACE (death, MI, and TVR) at 30 days and 1 year.
Primary Outcome
FFR is the ratio between the maximal myocardial flow measured in a diseased coronary artery and the theoretical maximal blood flow in the same territory in the absence of the stenosis, measured using adenosine induced hyperemia (aFFR) or contrast induced hyperemia (cFFR). Contrast FFR is being compared to the gold-standard adenosine FFR. An aFFR equal or less than 0.80 is the gold-standard cut-off to benefit from intervention. Reported as the percentage of agreement between aFFR and cFFR.
Interventions
- DRUG adenosine
- DRUG Iopamidol
- DEVICE Navvus® Catheter
- DEVICE CVi® Contrast Delivery System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2019-01-17 |
| Est. Completion | 2023-04-04 |
| Phase | Phase 4 |
What the finished NCT03557385 record still lists
NCT03557385 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 4 interventions - of which adenosine is the first listed.
NCT03557385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03557385 about?
NCT03557385 is a clinical study titled "Adenosine Contrast CorrELations in Evaluating RevAscularizaTION". The purpose of this study is to compare FFR measurements done with adenosine to FFR measurements done with contrast, where the contrast is injected using the ACIST CVi automated contrast injector. The ACCELERATION study will support a safer approach to FFR for patients by potentially reducing toxic...
What is the current status of trial NCT03557385?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 201 participants. The study started on 2019-01-17. Estimated completion is 2023-04-04.
What interventions are being tested in trial NCT03557385?
The interventions under investigation include: adenosine (DRUG), Iopamidol (DRUG), Navvus® Catheter (DEVICE), CVi® Contrast Delivery System (DEVICE).
Who is sponsoring clinical trial NCT03557385?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03557385's enrollment target sits among peer trials
201 406th of 2000 higher than 1,594 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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