Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
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
  • Drug: 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).
    Other names:
    • Contrast Fractional Flow Reserve Measurement
  • 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
    Other names:
    • Adenosine Fractional Flow Reserve Measurement
  • Device: Navvus® Catheter
    the NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing
  • Device: CVi® Contrast Delivery System
    The CVi® Contrast Delivery System will be used to deliver the contrast medium

More Details

Status
Active, not recruiting
Sponsor
Duke University

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.