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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 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 201 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03557385
The ClinicalTrials.gov registry entry for NCT03557385 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 201 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which adenosine is the first listed.
NCT03557385 reports 0 study locations.
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.
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