Adenosine Contrast CorrELations in Evaluating RevAscularizaTION (ACCELERATION)

Duke University

Status and phase: Completed; Phase 4

Conditions: Percutaneous Coronary Intervention

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03557385

Pro00093001

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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201 participants in 1 patient group

aFFR vs cFFR

Other group

Description:

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

Treatment:

Device: CVi® Contrast Delivery System

Device: Navvus® Catheter

Drug: adenosine

Drug: Iopamidol