Percutaneous Coronary InterventionPhase 4ACCELERATIONNCT03557385
Adenosine Contrast CorrELations in Evaluating RevAscularizaTION
A Phase 4 study testing Iopamidol, adenosine and Navvus® Catheter in people with Percutaneous Coronary Intervention, run by Duke University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- Iopamidol, adenosine and Navvus® Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Jan 2019to 4 Apr 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Mercy Hospital
Coon Rapids, Minnesota, 55433
Durham VA
Durham, North Carolina, 27701
Long Beach VA
Long Beach, California, 90822
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt
Nashville, Tennessee, 37212
About this study
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:
- 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.
- 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
- Being tested
- Iopamidol, adenosine, Navvus® Catheter, CVi® Contrast Delivery System
- Keywords
- Fractional Flow Reserve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IopamidolDrug
Also called Contrast Fractional Flow Reserve Measurement
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).
adenosineDrug
Also called Adenosine Fractional Flow Reserve Measurement
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
Navvus® CatheterDevice
the NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing
CVi® Contrast Delivery SystemDevice
The CVi® Contrast Delivery System will be used to deliver the contrast medium
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Iopamidol; Drug: adenosine; Device: Navvus® Catheter; Device: CVi® Contrast Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (2)
Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR)
(MACE: death, MI, and TVR) TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.
An MI is caused by decreased or complete cessation of blood flow to a portion of the myocardium.
Measured: 30 days post procedure
Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR)
(MACE: death, MI, and TVR) TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.
An MI is caused by decreased or complete cessation of blood flow to a portion of the myocardium.
Measured: 1 year post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start17 Jan 2019
- Primary completion4 May 2022
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Acist Medical Systems
- Responsible party
- Sponsor
- Investigators
- Rajesh Swaminathan, MD, Principal investigator, DCRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557385
- Sponsor's protocol ID
- Pro00093001
- Acronym
- ACCELERATION
- Status last verified
- Jul 2024
- First submitted
- 18 May 2018
- Last updated
- 5 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
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.
PubMed 40270240
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenosine Contrast CorrELations in Evaluating RevAscularizaTION
- ClinicalTrials.gov ID
- NCT03557385
- Acronym / sponsor ID
- ACCELERATION / Pro00093001
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- Fractional Flow Reserve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Acist Medical Systems
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 2 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aFFR vs cFFR | Other | Drug: Iopamidol, Drug: adenosine, Device: Navvus® Catheter, Device: CVi® Contrast Delivery SystemAll subjects will receive Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IopamidolAlso: Contrast Fractional Flow Reserve MeasurementaFFR 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). | Drug | aFFR vs cFFR |
| adenosineAlso: Adenosine Fractional Flow Reserve MeasurementFFR measurement with drug: adenosine. Intravenous adenosine will be administered at a rate of 140 μg/kg of body weight per minute x 2 minutes | Drug | aFFR vs cFFR |
| Navvus® Catheterthe NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing | Device | aFFR vs cFFR |
| CVi® Contrast Delivery SystemThe CVi® Contrast Delivery System will be used to deliver the contrast medium | Device | aFFR vs cFFR |
Primary outcome
Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR)
Time frame: Baseline
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.
Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves
Time frame: Baseline
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.
2 secondary outcomes
Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR)
Time frame: 30 days post procedure
Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR)
Time frame: 1 year post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40270240Swaminathan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajesh Swaminathan, MD principal investigator
DCRI
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iopamidol, adenosine and Navvus® Catheter in people with Percutaneous Coronary Intervention, run by Duke University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03557385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.