Adenosine Contrast CorrELations in Evaluating RevAscularizaTION

NCT03557385 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: Pro00093001
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 5

Brief Summary

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. 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. 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.

Conditions

Percutaneous Coronary Intervention

Keywords

Fractional Flow Reserve

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  30 days post procedure

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

  1 year post procedure

Study Arms (1)

aFFR vs cFFR

OTHER

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; Drug: adenosine; Device: Navvus® Catheter; Device: CVi® Contrast Delivery System

Interventions

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).

Also known as: Contrast Fractional Flow Reserve Measurement

aFFR vs cFFR

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

Also known as: Adenosine Fractional Flow Reserve Measurement

aFFR vs cFFR

Navvus® Catheter DEVICE

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

aFFR vs cFFR

CVi® Contrast Delivery System DEVICE

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

aFFR vs cFFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Acist Medical Systems: collaborator

Study Sites (5)

Long Beach VA

Long Beach, California, 90822, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Durham VA

Durham, North Carolina, 27701, United States

Location

Vanderbilt

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

Iopamidol; Adenosine

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Marjan Cobbaert
• Organization: Duke Clinical Research Institute

mr157@duke.edu

9196995638

Study Officials

• Rajesh Swaminathan, MD

  DCRI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 15, 2018
• Study Start: January 17, 2019
• Primary Completion: May 4, 2022
• Study Completion: April 4, 2023
• Last Updated: July 5, 2024
• Results First Posted: April 2, 2024

Record last verified: 2024-07

Locations

US (5)