Coronary Artery Disease
Conditions
Brief summary
The purpose of the study was to evaluate coronary artery flow reserve (CFR) following successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions by orbital atherectomy and stenting.
Detailed description
This is an acute, observational, prospective, multi-center clinical study, evaluating coronary flow reserve (CFR) using the Volcano FloWire®. Subjects will be evaluated after treatment with orbital atherectomy and stenting of de-novo severely calcified lesions, due to coronary artery disease. Subjects who undergo successful revascularization using the Diamondback 360® Coronary Orbital Atherectomy System (OAS) and stenting are eligible for enrollment. Coronary blood flow of enrolled subjects will be measured with the Volcano FloWire®, Doppler velocity data recorded intra-procedurally, and major adverse cardiac events (MACE) assessed at 24 hours or at discharge, whichever is earlier. Determination of CFR by Doppler flow measurements can assess physiological changes in the distal vascular bed. The primary endpoint of this study will evaluate coronary flow reserve after successful treatment of severely calcified coronary lesions using OAS and stent deployment. The secondary endpoint will measure the occurrence of post-procedural Major Adverse Cardiac Events (MACE), including cardiac death, acute myocardial infarction (Q wave or non-Q wave), and target vessel revascularization.
Interventions
DEVICECoronary Orbital Atherectomy plus Stenting
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all inclusion criteria and no
Exclusion criteria
to be eligible to participate in the study. Inclusion Criteria 1. Subjects must be at least 18 years of age. 2. Subjects must be scheduled for percutaneous coronary intervention involving stent deployment in de novo coronary lesions. 3. The target vessel must be a de-novo coronary artery with a severely calcified lesion. 4. The target vessel reference diameter must be ≥ 2.0mm and ≤ 4.0 mm. 5. The lesion length must not exceed 40 mm. 6. The target vessel must have a thrombolysis in myocardial infarction (TIMI) flow 3 at baseline. 7. The target lesion must have fluoroscopic, intravascular ultrasound (IVUS) or optical coherence tomograph (OCT) evidence of severe calcium deposit at the lesion site based on the protocol definition. 8. The lesion must be crossable with the ViperWire Advance® coronary guide wire. 9. Successful revascularization using OAS and stent deployment as demonstrated by no evidence of stent dissection and no more than 50% stenosis proximal to the stent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coronary Flow Reserve (CFR) | Intra-procedurally following successful stent placement. Average procedure time 56 minutes. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events (MACE) | At 24 hours or at time of hospital discharge, whichever occurred first | MACE: cardiac death, acute myocardial infarction (Q wave or non-Q wave), or target vessel revascularization. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Coronary Flow Reserve Single arm - all enrolled subjects had successful coronary revascularization via orbital atherectomy and stenting. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Coronary Flow Reserve |
|---|---|
| Age, Continuous | 70.6 years STANDARD_DEVIATION 9.3 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized White | 14 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Coronary Flow Reserve (CFR)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Eligible Subjects | Coronary Flow Reserve (CFR) | 2.23 Ratio | Standard Deviation 0.33 |
Secondary
Major Adverse Cardiac Events (MACE)
MACE: cardiac death, acute myocardial infarction (Q wave or non-Q wave), or target vessel revascularization.
Time frame: At 24 hours or at time of hospital discharge, whichever occurred first
Population: MACE is evaluated per protocol, on subjects with successful PCI treatment of severely calcified coronary lesions
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Eligible Subjects | Major Adverse Cardiac Events (MACE) | 0 participants |