Adenosine Contrast CorrELations in Evaluating RevAscularizaTION (ACCELERATION)

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.

Study Overview

• Status: Completed
• Conditions: Percutaneous Coronary Intervention
• Intervention / Treatment: Drug: Iopamidol; Drug: adenosine; Device: Navvus® Catheter; Device: CVi® Contrast Delivery System

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90822
      • Long Beach VA
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy Hospital
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Durham VA
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Have the capacity to understand and sign an informed consent or have a legally authorized representative (LAR) that can understand and sign an informed consent prior to initial arteriotomy access
2. Age > 18 years of age at the time of signing the informed consent
3. Clinically stable and undergoing non-emergent cardiac catheterization for appropriate indications
4. Willing to be contacted by telephone at 30 days (if no standard of care visit) and at 1 year with chart review for events.
5. Target vessel with an intermediate lesion of 40-70% stenosis by angiographic assessment (a visual estimation by the operator). Serial lesions, diffuse disease, or ostial lesions ("all-comer" lesions) are acceptable if the operator would normally perform FFR and proceed with PCI (or other revascularization) if positive.

Exclusion Criteria:

1. Any condition associated with a life expectancy of less than 1 year
2. Participation in another clinical study using an investigational agent or device within the past 3 months
3. Ejection fraction ≤ 35%
4. Creatinine ≥ 2
5. Severe valvular heart disease
6. Decompensated acute diastolic or systolic heart failure
7. Bronchospastic chronic obstructive pulmonary disease or other intolerance to adenosine
8. ST-segment elevation myocardial infarction culprit lesion or lesions with any thrombus burden after diagnostic angiography
9. Lesions with severe calcification after diagnostic angiography
10. Lesions in a target vessel supplied by a patent graft

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: aFFR vs cFFR; All subjects will receive Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System

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).; Other Names: Contrast Fractional Flow Reserve Measurement; 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; Other Names: Adenosine Fractional Flow Reserve Measurement; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR)	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.	Baseline
Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves	The qualitative method comparison assesses the agreement as to which lesion is flow limiting. The contrast FFR measurement that corresponds to adenosine FFR measurement value of 0.8 will be used as the cutoff value for determining whether a lesion is flow limiting for contrast FFR. Reported as the percentage of agreement between aFFR and cFFR.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR)	(MACE: death, MI, and TVR) TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion. An MI is caused by decreased or complete cessation of blood flow to a portion of the myocardium.	30 days post procedure
Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR)	(MACE: death, MI, and TVR) TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion. An MI is caused by decreased or complete cessation of blood flow to a portion of the myocardium.	1 year post procedure

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Acist Medical Systems
• Investigators: Principal Investigator: Rajesh Swaminathan, MD, DCRI

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2019
• Primary Completion (Actual): May 4, 2022
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Fractional Flow Reserve
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Purinergic Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Adenosine
• Other Study ID Numbers: Pro00093001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No