Adenosine Contrast CorrELations in Evaluating RevAscularizaTION (ACCELERATION)

• ClinicalTrials.gov Identifier: NCT03557385
• Recruitment Status: Recruiting
• First Posted: June 15, 2018
• Last Update Posted: February 17, 2022
• Sponsor: Duke University
• Collaborator: Acist Medical Systems
• Information provided by (Responsible Party): Duke University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Percutaneous Coronary Intervention	Drug: Iopamidol; Drug: adenosine; Device: Navvus® Catheter; Device: CVi® Contrast Delivery System	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Adenosine Contrast CorrELations in Evaluating RevAscularizaTION
• Actual Study Start Date: January 17, 2019
• Estimated Primary Completion Date: March 2022
• Estimated Study Completion Date: March 2022

Arms and Interventions

Arm

Intervention/treatment

aFFR vs cFFR; 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

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).; Other Name: Contrast Fractional Flow Reserve Measurement; Drug: 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; Other Name: Adenosine Fractional Flow Reserve Measurement; Device: Navvus® Catheter; the NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing; Device: CVi® Contrast Delivery System; The CVi® Contrast Delivery System will be used to deliver the contrast medium

Outcome Measures

Primary Outcome Measures :

1. Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR) [ Time Frame: Baseline ]
   Subjects' aFFR measurement will be plotted on the x-axis, and their cFFR measurement will be plotted on the y-axis. The plot will be examined for highly influential points and heterogeneity of variance along the range of measurement values. In addition, several types of difference plots similar to the Bland-Altman plot will be used to examine whether the size of the variance changes with changing measurement value, the bias changes with changing measurement value and the coefficient of variation changes with changing measurement value. Then, the appropriate model will be applied to describe the relationship of aFFR measured values to their corresponding cFFR values
2. 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. If a lesion has an adenosine FFR measurement the cutoff value of 0.8, then the lesion is considered flow limiting. Using the model developed above, 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.
3. Assessment of the Relationship Between Post-Percutaneous Coronary Intervention Fractional Flow Reserves and Long-Term Clinical Outcomes [ Time Frame: 1 year ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Marjan Cobbaert, MPH; 919-864-0910; mr157@duke.edu

Locations

United States, California

Long Beach VA; Recruiting

Long Beach, California, United States, 90822

Contact: Najeeb Shirwany

United States, Minnesota

Mercy Hospital; Recruiting

Coon Rapids, Minnesota, United States, 55433

Contact: Stephannie Knutson

University of Minnesota; Recruiting

Minneapolis, Minnesota, United States, 55455

Contact: Coley Landvik

United States, North Carolina

Durham VA; Recruiting

Durham, North Carolina, United States, 27701

Contact: Kathy A

Principal Investigator: Rajesh Swaminathan, MD

United States, Tennessee

Vanderbilt; Recruiting

Nashville, Tennessee, United States, 37212

Contact: Terry Weyand

Sponsors and Collaborators

Duke University

Acist Medical Systems

Investigators

• Principal Investigator: Rajesh Swaminathan, MD; DCRI

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03557385
• Other Study ID Numbers: Pro00093001
• First Posted: June 15, 2018
• Last Update Posted: February 17, 2022
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Duke University:

Fractional Flow Reserve

Additional relevant MeSH terms:

Adenosine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Vasodilator Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Purinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action