Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: Diamondback 360 Extended Length Orbital Atherectomy System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 years Subject is willing and able to sign the IRB-approved informed consent form (ICF) Subject presents with a Rutherford Classification of 2 to 5 Subject has a positive Allen's Test Subject to undergo peripheral angiography and/or PVI via TRA approach per physician discretion Index Procedure Inclusion Criteria: Physician obtains successful radial artery access (Note: snuffbox access is allowed) Target lesion appropriate (i.e. location/morphology) for OA treatment via TRA within target area OAS use attempted (defined as ViperWire introduced into the body) Exclusion Criteria: Subject has no palpable radial artery on the planned access arm Subject has a previous failed radial access attempt on planned access arm Subject has a dialysis fistula on planned access arm Subject has a known subclavian stenosis or occlusion Subject has a previous subclavian stent or previous subclavian intervention Subject has a shunt in the radial artery on the planned access arm Subject has evidence of osteomyelitis Subject is currently participating in an investigational drug or device study Subject is pregnant within the study period Index Procedure Exclusion Criteria Physician unable to obtain radial artery access Physician determines TRA is not acceptable due to patient anatomy, lesion characteristics, and/or disease severity OAS use not attempted (defined as ViperWire introduced into the body) Prior to insertion of ViperWire: Femoral access is obtained Unsuccessful peripheral intervention A reportable adverse event has occurred

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Diamondback 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours |