Adenosine Contrast CorrELations in Evaluating RevAscularizaTION

PHASE4CompletedINTERVENTIONAL
Enrollment

201

Participants

Timeline

Start Date

January 17, 2019

Primary Completion Date

May 4, 2022

Study Completion Date

April 4, 2023

Conditions
Percutaneous Coronary Intervention
Interventions
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

Trial Locations (5)

27701

Durham VA, Durham

37212

Vanderbilt, Nashville

55433

Mercy Hospital, Coon Rapids

55455

University of Minnesota, Minneapolis

90822

Long Beach VA, Long Beach

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Acist Medical Systems

INDUSTRY

lead

Duke University

OTHER