Adenosine Contrast CorrELations in Evaluating RevAscularizaTION

• Iopamidol (Drug), also known as Contrast Fractional Flow Reserve Measurement: 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 (Drug), also known as Adenosine Fractional Flow Reserve Measurement: 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 (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

• Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR) [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.
• Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves [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

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

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR) (Primary), Number, proportion of lesions with agreement: aFFR vs cFFR 0.8922 (0.8403 to 0.9441)
• Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves (Primary), Number, proportion of lesions with agreement: aFFR vs cFFR 0.8912 (0.8445 to 0.9379)
• Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR) (Secondary), Number, Events (composite of death, MI, or TVR): Per Protocol Study Population 3
• Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR) (Secondary), Number, Events (composite of death, MI, or TVR): Per Protocol Study Population 13

Adverse events

Time frame: 1 year post procedure

Serious adverse events by term

• Results publication: Swaminathan RV, Marquis-Gravel G, Boivin-Proulx LA, Benjamin DK, Rikhi A, Raveendran G, Chambers JW, Seto AH, Bagai J, White R, Gutierrez JA, Povsic TJ, Rao SV, Krucoff MW. Adenosine Contrast Correlations in Evaluating Revascularization: The (ACCELERATION) Study. Circ Cardiovasc Interv. 2025 Jun;18(6):e015240. doi: 10.1161/CIRCINTERVENTIONS.125.015240. Epub 2025 Apr 24. PMID 40270240

• Study Protocol and Statistical Analysis Plan (PDF, 2022-03-23)

• Rajesh Swaminathan, MD, Principal investigator, DCRI