Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

The percentage of subjects with the following, post-procedure:

• ≤50% residual stenosis post OAD + POBA [Angiographic Core Lab assessed] and,
• No OAS-related severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure [CEC adjudicated].

The percentage changes in diameter stenosis of the target lesion at each stage of the procedure: Baseline, Post OAD, Post POBA and Post DCB [Angiographic Core Lab assessed].

Acute technical success defined per the Peripheral Academic Research Consortium (PARC) definition of achievement of a final residual stenosis <30% for stented and <50% for non-stented subjects by angiography at the end of the procedure [Angiographic Core Lab assessed] without severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure [CEC adjudicated].

DCB Device Success defined as the ability to achieve successful delivery and deployment of all DCB to the target lesion as described per the Instructions for Use (IFU) within 3 minutes of insertion without removal and use of an additional device.

Target Vessel Patency is a binary composite endpoint comprised of:

• CEC adjudicated absence of clinically driven repeat procedure performed for ≥50% stenosis confirmed by angiography within all or part of the target lesion after documentation of recurrent clinical symptoms of PAD following clinical trial treatment procedure (i.e. clinically-driven TLR) occurring at any time-point on, or prior to the 6-month visit date and,
• a Duplex Ultrasound Core Lab assessed PSVR value of ≤2.4 (or equivalent by visual assessment if the lesion is non-patent and the PSVR cannot be numerically calculated).

The vessel is considered patent if both criteria are met at the time of assessment.

Rate of severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure [CEC adjudicated]

Acute procedural success is defined as both acute technical success and absence of death, stroke, myocardial infarction (MI), acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery within 72 hours of the clinical trial treatment [CEC adjudicated].

Major Adverse Event (MAE) rate at 30 days and 6 months (CEC adjudicated) was defined as:

• All-cause death through 30 days or
• Major amputation of the target limb or
• Clinically-driven TLR

Rutherford Classification; Class 0: Asymptomatic; no hemodynamically significant occlusive disease.

Class 1: Mild Claudication; there is no limitation with ordinary physical activities (e.g., walking several blocks, climbing stairs). Limiting symptoms may occur with marked exertion (e.g., strenuous, rapid or prolonged exertion at work or recreation).

Class 2: Moderate Claudication; there is a slight limitation of ordinary physical activities (e.g., walking uphill, or more than two level blocks, or climbing stairs rapidly). Subject is comfortable at rest.

Class 3: Severe Claudication; there is marked limitation of ordinary physical activities (e.g., walking 1-2 level blocks or climbing one flight of stairs). Subject is comfortable at rest.

Class 4: Ischemic rest pain. Class 5: Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia.

Class 6: Major tissue loss extending above transmetatarsal level; functional foot no longer salvageable.

Rutherford Classification; Class 0: Asymptomatic; no hemodynamically significant occlusive disease.

Class 1: Mild Claudication; there is no limitation with ordinary physical activities (e.g., walking several blocks, climbing stairs). Limiting symptoms may occur with marked exertion (e.g., strenuous, rapid or prolonged exertion at work or recreation).

Class 2: Moderate Claudication; there is a slight limitation of ordinary physical activities (e.g., walking uphill, or more than two level blocks, or climbing stairs rapidly). Subject is comfortable at rest.

Class 3: Severe Claudication; there is marked limitation of ordinary physical activities (e.g., walking 1-2 level blocks or climbing one flight of stairs). Subject is comfortable at rest.

Class 4: Ischemic rest pain. Class 5: Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia.

Class 6: Major tissue loss extending above transmetatarsal level; functional foot no longer salvageable.

The Ankle-Brachial Index (ABI) is a simple, non-invasive test used to assess peripheral artery disease (PAD). It compares the blood pressure measured at the ankle with the blood pressure measured at the arm (brachial artery).