Adenosine Contrast CorrELations in Evaluating RevAscularizaTION

Percutaneous Coronary Intervention Clinical Trial

— ACCELERATION  

Official title:

Adenosine Contrast CorrELations in Evaluating RevAscularizaTION

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557385
• Other study ID #: Pro00093001
• Status: Completed
• Phase: Phase 4
• Start date: January 17, 2019
• Est. completion date: April 4, 2023

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: April 4, 2023
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

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).
• 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

Device:
• Navvus® Catheter
the NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing
• CVi® Contrast Delivery System
The CVi® Contrast Delivery System will be used to deliver the contrast medium

Locations

Country	Name	City	State
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Durham VA	Durham	North Carolina
United States	Long Beach VA	Long Beach	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Acist Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Baseline
Secondary	Assessment of the Relationship Between Post-Percutaneous Coronary Intervention Fractional Flow Reserves and Long-Term Clinical Outcomes	assesses whether there is a relationship between final PCI FFR (resting, dPR, cFFR, aFFR) and long-term outcomes (death, MI, TVR). The model will include the known covariates for predicting revascularization outcomes: stent length, vessel diameter, diabetes, history of cardiovascular disease, and multi-vessel disease.	1 year