Trial Outcomes & Findings for Adenosine Contrast CorrELations in Evaluating RevAscularizaTION (NCT NCT03557385)
NCT ID: NCT03557385
Last Updated: 2024-07-05
Results Overview
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.
COMPLETED
PHASE4
201 participants
Baseline
2024-07-05
Participant Flow
Participant milestones
| Measure |
aFFR and 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
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
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
|
|---|---|
|
aFFR
STARTED
|
201
|
|
aFFR
COMPLETED
|
201
|
|
aFFR
NOT COMPLETED
|
0
|
|
cFFR
STARTED
|
201
|
|
cFFR
COMPLETED
|
201
|
|
cFFR
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adenosine Contrast CorrELations in Evaluating RevAscularizaTION
Baseline characteristics by cohort
| Measure |
aFFR vs cFFR
n=201 Participants
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
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
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
|
|---|---|
|
Age, Continuous
|
67.22 years
STANDARD_DEVIATION 8.63 • n=99 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
195 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
182 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
201 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: All subjects received Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System. The FFR tracings of 217 lesions from 201 participants were assessed for quality and validity by the Fractional Flow Reserve Core Lab. After qualitative review, 192 FFR pairs were included in the analysis.
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.
Outcome measures
| Measure |
aFFR vs cFFR
n=192 lesions
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 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 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
|
|---|---|
|
Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR)
|
0.8922 proportion of lesions with agreement
Interval 0.8403 to 0.9441
|
PRIMARY outcome
Timeframe: BaselinePopulation: All subjects received Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System. The FFR tracings of 217 lesions from 201 participants were assessed for quality and validity by the Fractional Flow Reserve Core Lab. After qualitative review, 192 FFR pairs were included in the analysis.
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.
Outcome measures
| Measure |
aFFR vs cFFR
n=192 lesions
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 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 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
|
|---|---|
|
Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves
|
0.8912 proportion of lesions with agreement
Interval 0.8445 to 0.9379
|
SECONDARY outcome
Timeframe: 30 days post procedurePopulation: After quality assessment, 178 patients were included in the analysis
(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.
Outcome measures
| Measure |
aFFR vs cFFR
n=178 Participants
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 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 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
|
|---|---|
|
Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR)
|
3 Events (composite of death, MI, or TVR)
|
SECONDARY outcome
Timeframe: 1 year post procedurePopulation: After quality assessment, 178 patients were included in the analysis
(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.
Outcome measures
| Measure |
aFFR vs cFFR
n=178 Participants
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 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 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
|
|---|---|
|
Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR)
|
13 Events (composite of death, MI, or TVR)
|
Adverse Events
aFFR vs cFFR
Serious adverse events
| Measure |
aFFR vs cFFR
n=201 participants at risk
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 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 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
|
|---|---|
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Cardiac disorders
Myocardial infarction
|
3.0%
6/201 • 1 year post procedure
Adverse Event data was not collected "per arm" because aFFR and cFFR measurements were made at the same timepoints. Reported AEs include serious adverse events (SAEs) related to the NAVVUS Rxi FFR microcatheter system.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place