NCT03557385

Adenosine Contrast CorrELations in Evaluating RevAscularizaTION

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DRUG	Iopamidol	aFFR measurement with drug: Iopamidol (ISOVUE®-370). Subjects will receive an injector-based intracoronary bolus of contrast * Rate of 4 mL/sec, volume of 10 cc (left coronary system) * Rate of 3 mL/sec, volume of 6 cc (right coronary system).
DRUG	adenosine	FFR measurement with drug: adenosine. Intravenous adenosine will be administered at a rate of 140 μg/kg of body weight per minute x 2 minutes
DEVICE	Navvus® Catheter	the NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing
DEVICE	CVi® Contrast Delivery System	The CVi® Contrast Delivery System will be used to deliver the contrast medium

Timeline

• Start date: 2019-01-17
• Primary completion: 2022-05-04
• Completion: 2023-04-04
• First posted: 2018-06-15
• Last updated: 2024-07-05
• Results posted: 2024-04-02

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study