drugset / Trial / NCT03557385

Adenosine Contrast CorrELations in Evaluating RevAscularizaTION

NCT03557385

Phase 4 Completed 201 enrolled Duke University Acist Medical Systems · collab
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2019-01-17
Primary completion
2022-05-04
Completion
2023-04-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Adenosine Small molecule 140 ug/kg Intravenous
Subject Iopamidol Diagnostic / imaging agent 6 ml Other
Subject Iopamidol Diagnostic / imaging agent 10 ml Other

Indications

No indication recorded.