Clinical trial NCT03557385: Adenosine Contrast CorrELations in Evaluating RevAscularizaTION
Official title: Adenosine Contrast CorrELations in Evaluating RevAscularizaTION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Percutaneous Coronary Intervention
Keywords: Fractional Flow Reserve
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Acist Medical Systems
First posted: 2018-06-15
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR)
timeFrame: Baseline
measure: Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves
timeFrame: Baseline
Secondary outcomes:
measure: Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR)
timeFrame: 30 days post procedure
measure: Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR)
timeFrame: 1 year post procedure
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach VA
state: California
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Durham
country: United States
facility: Durham VA
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt
state: Tennessee
Study officials:
affiliation: DCRI
name: Rajesh Swaminathan, MD
role: PRINCIPAL_INVESTIGATOR
References: