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

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