Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease (RAPID)

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease, Critical Limb Ischemia, Claudication, Percutaneous Vascular Intervention, Peripheral Vascular Intervention Read More

Inclusion Criteria:

• General Inclusion

  1. At least 18 years of age;
  2. Symptomatic disease: presence of critical limb ischemia (including tissue loss or rest pain), or lifestyle-limiting claudication requiring intervention in iliac and/or superficial femoral arteries;
  3. The subject or the legally authorized representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.
• Angiographic Inclusion

Presence of superficial femoral artery and/or iliac stenosis (>50%) or occlusion of up to 50 mm in length as determined by angiogram prior to index interventional procedure.

Exclusion Criteria:

• General Exclusion

  1. Failure/inability/unwillingness to provide informed consent;
  2. Target vessel has been previously treated with bypass;
  3. Has an abdominal aortic aneurysm contiguous with the iliac artery target lesion;
  4. Has contraindication to anticoagulation;
  5. Has bleeding or a hypercoagulability disorder;
  6. Thrombocytopenia;
  7. Elevated international normalized ratio (>1.5);
  8. Elevated serum creatinine (≥2.5 mg/dL);
  9. Active infection;
  10. Contraindication to contrast; or
  11. Enrolled in concurrent clinical study.

• Angiographic Exclusion

  1. Target vessel:

     1. shows evidence of previous dissection or perforation, or
     2. has adjacent acute thrombus;
  2. Lesion is highly calcified;
  3. Lesion requires use of any atherectomy device during the procedure;
  4. Has a pre-existing target artery aneurysm or perforation or dissection of the target artery prior to initiation of the interventional procedure.