Adenosine Contrast CorrELations in Evaluating RevAscularizaTION
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2019 |
| Start Date: | January 11, 2019 |
| End Date: | August 2020 |
| Contact: | Marjan Cobbaert, MPH |
| Email: | mr157@duke.edu |
| Phone: | 919-864-0910 |
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.
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.
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
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