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Completed

NCT Number: NCT03557385

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 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.

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Key information

Conditions

Percutaneous Coronary Intervention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Long Beach VA, Long Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Age > 18 years of age at the time of signing the informed consent
  • Clinically stable and undergoing non-emergent cardiac catheterization for appropriate indications
  • Willing to be contacted by telephone at 30 days (if no standard of care visit) and at 1 year with chart review for events.
  • 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

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

Treatment and study plan

Iopamidol

Drug

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

Adenosine

Drug

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

Navvus® Catheter

Device

the NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing

CVi® Contrast Delivery System

Device

The CVi® Contrast Delivery System will be used to deliver the contrast medium

Primary outcomes

  1. Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR)

    Time frame: Baseline

    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.

  2. Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves

    Time frame: Baseline

    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.

Secondary outcomes

  1. Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR)

    Time frame: 30 days post procedure

    (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.

  2. Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR)

    Time frame: 1 year post procedure

    (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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Acist Medical Systems

Registry information

Acronym: ACCELERATION

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jun 15, 2018
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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