Trial Outcomes & Findings for Coronary Flow Reserve Following Orbital Atherectomy (NCT NCT02339545)
NCT ID: NCT02339545
Last Updated: 2023-07-18
Results Overview
CFR was measured after successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions. It was calculated from coronary blood flow velocity measurements, which were derived from Doppler-velocity wire data recorded in real time. The CFR formula utilized was APVp/APVb, where APVb is the average peak velocity at baseline and APVp is peak hyperemia.
COMPLETED
15 participants
Intra-procedurally following successful stent placement. Average procedure time 56 minutes.
2023-07-18
Participant Flow
Participant milestones
| Measure |
Coronary Flow Reserve
Single arm - all enrolled subjects had successful coronary revascularization via orbital atherectomy and stenting.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Coronary Flow Reserve Following Orbital Atherectomy
Baseline characteristics by cohort
| Measure |
Coronary Flow Reserve
n=15 Participants
Single arm - all enrolled subjects had successful coronary revascularization via orbital atherectomy and stenting.
|
|---|---|
|
Age, Continuous
|
70.6 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Intra-procedurally following successful stent placement. Average procedure time 56 minutes.Population: CFR is analyzed per protocol, which may require Doppler measurement in a control vessel in addition to the target vessel. Only subjects where this procedure is followed are included in the data set. The CFR formula is a ratio: APVp/APVb, where APV = average peak velocity (cm/sec). APVb = velocity at baseline and APVp = velocity at peak hyperemia.
CFR was measured after successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions. It was calculated from coronary blood flow velocity measurements, which were derived from Doppler-velocity wire data recorded in real time. The CFR formula utilized was APVp/APVb, where APVb is the average peak velocity at baseline and APVp is peak hyperemia.
Outcome measures
| Measure |
All Eligible Subjects
n=8 Participants
All subjects whose Doppler flow measurements facilitated calculation of coronary flow reserve
|
|---|---|
|
Coronary Flow Reserve (CFR)
|
2.23 Ratio
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: At 24 hours or at time of hospital discharge, whichever occurred firstPopulation: MACE is evaluated per protocol, on subjects with successful PCI treatment of severely calcified coronary lesions
MACE: cardiac death, acute myocardial infarction (Q wave or non-Q wave), or target vessel revascularization.
Outcome measures
| Measure |
All Eligible Subjects
n=15 Participants
All subjects whose Doppler flow measurements facilitated calculation of coronary flow reserve
|
|---|---|
|
Major Adverse Cardiac Events (MACE)
|
0 participants
|
Adverse Events
All Enrolled Subjects
Serious adverse events
| Measure |
All Enrolled Subjects
n=15 participants at risk
All subjects who have had successful revascularization by orbital atherectomy and stenting
|
|---|---|
|
Cardiac disorders
Cardiac Death
|
0.00%
0/15 • At 24 hours or at discharge, whichever was earlier.
MACE defined as: Cardiac death, acute myocardial infarction (Q wave or non-Q wave), target vessel revascularization.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60