Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty

Although the association between the drug coated balloon (DCB) therapy and limb outcomes
could not be clearly linked to the use of antiproliferative agents, the findings of
paclitaxel crystals downstream of the treated lesions, although in small amounts, has raised
concerns about the safety of such therapy in patients with critical limb ischemia (CLI) and
tissue loss.

These concerns, however, may not translate to patients with femoropopliteal occlusive disease
as the amount of paclitaxel reaching the foot may be even smaller after being filtered by the
calf musculature.

Since the use of DCB angioplasty in the Superficial Femoral Artery (SFA) and popliteal has
been shown to deliver significantly more durable outcomes compared to standard angioplasty
alone, with reported primary patency rates of almost 90% at one year, this therapy may even
be more needed in patients with tissue loss where prolonged patency is essential for wound
healing.

Inclusion Criteria:

- Patient population: all patients with CLI (critical limb ischemia) and tissue loss
scheduled for endovascular intervention for femoral popliteal occlusive or multilevel
disease.

- Patient or patient's legal representative have been informed of the nature of the
study, agrees to participate and has signed an Ethical Committee approved consent form

- Female patients of childbearing potential have a negative pregnancy test ≤7 days
before the procedure and are willing to use a reliable method of birth control for the
duration of study participation

- Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior
to the study procedure with Rutherford Category 5 or 6

- General Angiographic Inclusion Criteria

- Single or multiple lesions with ≥70% diameter stenosis (DS) of different lengths in
the SFA and/or popliteal arteries.

- Iliac inflow or Tibial outflow interventions can be done at the discretion of the
investigator with standard balloon Percutaneous Transluminal Angioplasty (PTA)

Exclusion Criteria:

- Patient unwilling or unlikely to comply with Follow-Up schedule

- Aneurysm in the target vessel

- Acute thrombus in the target limb

- Sensitivity to Paclitaxel

- Immunosuppressed patients (transplant, chemotherapy, etc.)