Adenosine Contrast CorrELations in Evaluating RevAscularizaTION

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-17

Study Completion Date

2023-04-04

Brief Summary

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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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Detailed Description

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Conditions

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Percutaneous Coronary Intervention

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Iopamidol

Intervention Type 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).

adenosine

Intervention Type 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

Navvus® Catheter

Intervention Type DEVICE

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

CVi® Contrast Delivery System

Intervention Type DEVICE

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

Interventions

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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).

Intervention Type 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

Intervention Type DRUG

Navvus® Catheter

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

Intervention Type DEVICE

CVi® Contrast Delivery System

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

Intervention Type DEVICE

Other Intervention Names

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Contrast Fractional Flow Reserve Measurement Adenosine Fractional Flow Reserve Measurement

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No