Peripheral Artery Disease
Conditions
Brief summary
The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.
Detailed description
The purpose of this study is to prospectively evaluate acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for treatment of peripheral artery disease (PAD) in lower extremity lesions.
Interventions
DEVICEDiamondback 360 Extended Length Orbital Atherectomy System
All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.
Sponsors
Abbott Medical Devices
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥ 18 years 2. Subject is willing and able to sign the IRB-approved informed consent form (ICF) 3. Subject presents with a Rutherford Classification of 2 to 5 4. Subject has a positive Allen's Test 5. Subject to undergo peripheral angiography and/or PVI via TRA approach per physician discretion Index Procedure Inclusion Criteria: 1. Physician obtains successful radial artery access (Note: snuffbox access is allowed) 2. Target lesion appropriate (i.e. location/morphology) for OA treatment via TRA within target area 3. OAS use attempted (defined as ViperWire introduced into the body)
Exclusion criteria
1. Subject has no palpable radial artery on the planned access arm 2. Subject has a previous failed radial access attempt on planned access arm 3. Subject has a dialysis fistula on planned access arm 4. Subject has a known subclavian stenosis or occlusion 5. Subject has a previous subclavian stent or previous subclavian intervention 6. Subject has a shunt in the radial artery on the planned access arm 7. Subject has evidence of osteomyelitis 8. Subject is currently participating in an investigational drug or device study 9. Subject is pregnant within the study period Index Procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success: | Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure) | Successful completion of OA (orbital atherectomy) treatment of target lesion via transradial access without serious transradial access (TRA) related events. Serious TRA related events consist of: Serious TRA site bleeding, serious TRA site hematoma, serious radial artery spasm, serious hand ischemia, stroke, Transient Ischemic Attach (TIA), Serious nerve damage, perforation, TRA site pseudoaneurysm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success: | Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours | Treatment success is defined as \<50% residual stenosis post-procedure and without significant angiographic complications without stent placement, or \<30% residual stenosis post-procedure and without significant angiographic complications with stent placement. |
Countries
United States
Participant flow
Pre-assignment details
Following physician assessment of patient and general inclusion/exclusion and informed consent signature, subjects were eligible for enrollment pending index procedure inclusion and exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| OAS Use Via Transradial Access (TRA) All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | OAS Use Via Transradial Access (TRA) |
|---|---|
| Age, Continuous | 70.9 Years STANDARD_DEVIATION 10.3 |
| Baseline Rutherford Clinical Category Ischemic Rest Pain (4) | 12 Participants |
| Baseline Rutherford Clinical Category Minor Tissue Loss (5) | 1 Participants |
| Baseline Rutherford Clinical Category Moderate Claudication (2) | 6 Participants |
| Baseline Rutherford Clinical Category Severe Claudication (3) | 31 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 4 Participants |
| Race/Ethnicity, Customized White | 33 Participants |
| Region of Enrollment United States | 50 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 2 / 50 |
Outcome results
Primary
Procedural Success:
Successful completion of OA (orbital atherectomy) treatment of target lesion via transradial access without serious transradial access (TRA) related events. Serious TRA related events consist of: Serious TRA site bleeding, serious TRA site hematoma, serious radial artery spasm, serious hand ischemia, stroke, Transient Ischemic Attach (TIA), Serious nerve damage, perforation, TRA site pseudoaneurysm.
Time frame: Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OAS Use Via Transradial Access (TRA) | Procedural Success: | 49 Participants |
Secondary
Treatment Success:
Treatment success is defined as \<50% residual stenosis post-procedure and without significant angiographic complications without stent placement, or \<30% residual stenosis post-procedure and without significant angiographic complications with stent placement.
Time frame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OAS Use Via Transradial Access (TRA) | Treatment Success: | 49 Participants |