Adenosine Contrast CorrELations in Evaluating RevAscularizaTION

Study Overview
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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: 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. 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.

Official Title
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Adenosine Contrast CorrELations in Evaluating RevAscularizaTION

Conditions
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Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Iopamidol
* Drug: adenosine
* Device: Navvus® Catheter
* Device: CVi® Contrast Delivery System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: aFFR vs cFFR<br>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<br>* 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).<br>* Other names: Contrast Fractional Flow Reserve Measurement;Drug: adenosine<br>* 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<br>* Other names: Adenosine Fractional Flow Reserve Measurement;Device: Navvus® Catheter<br>* the NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing<br>Device: CVi® Contrast Delivery System<br>* The CVi® Contrast Delivery System will be used to deliver the contrast medium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR) | Subjects' aFFR measurement will be plotted on the x-axis, and their cFFR measurement will be plotted on the y-axis. The plot will be examined for highly influential points and heterogeneity of variance along the range of measurement values. In addition, several types of difference plots similar to the Bland-Altman plot will be used to examine whether the size of the variance changes with changing measurement value, the bias changes with changing measurement value and the coefficient of variation changes with changing measurement value. Then, the appropriate model will be applied to describe the relationship of aFFR measured values to their corresponding cFFR values | 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. If a lesion has an adenosine FFR measurement the cutoff value of 0.8, then the lesion is considered flow limiting. Using the model developed above, 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the Relationship Between Post-Percutaneous Coronary Intervention Fractional Flow Reserves and Long-Term Clinical Outcomes | assesses whether there is a relationship between final PCI FFR (resting, dPR, cFFR, aFFR) and long-term outcomes (death, MI, TVR). The model will include the known covariates for predicting revascularization outcomes: stent length, vessel diameter, diabetes, history of cardiovascular disease, and multi-vessel disease. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fractional Flow Reserve