Results of the Treatment of Medium and Long de Novo and Restenotic Lesions in the Superficial Femoral Artery and/or Popliteal Artery With Primary or Salvage Pulsar® -18 t3 Stent

Results of the Treatment of Medium and Long de Novo and Restenotic Lesions in the Superficial Femoral Artery and/or Popliteal Artery With Primary or Salvage Pulsar® -18 t3 Stent

The purpose of this post-authorization registry is to describe the clinical outcomes of de novo and restenotic lesions in the superficial femoral and/or popliteal artery treated with the PULSAR® -18 T3 stent, implanted both primary and salvage.

Post-authorization, prospective and multicenter registry to evaluate the clinical results of the PULSAR® -18 T3 stent, in the treatment of de novo or restenotic lesions of the superficial femoral and/or popliteal artery, primarily as salvage, in a population of patients residing in Spain and in "real life" conditions.

In this registry, data will be collected from approximately 100 consecutive patients who have been treated with the PULSAR® -18 T3 Stent.

Subjects with PAD treated with the PULSAR® -18 T3 Stent will be assessed for eligibility for the registry and will be consecutively included in the registry. Once informed consent is obtained, the required data will be collected.

Inclusion Criteria:

I1. Patients with documented PAD from the AFS and/or AP, classified as having intermittent claudication or critical limb ischemia (CLI), with a Rutherford score between 3 and 5.

I2. Age ≥ 55 years. I3. The target lesion consists of one or multiple de novo or restenotic lesions > 5 cm.

I4. Adequate run-off distal circulation to the foot (at least one patent, pre-existing, or successfully restored native distal vessel before beginning treatment of the target lesion).

I5. Adequate in-flow defined as, stenosis ≤ 30% of the diameter (either pre-existing or successfully reestablished before starting treatment of the target lesion).

I6. CI signed and dated.

Exclusion Criteria:

E1. Failure to successfully cross the target lesion with a guidewire (successful crossing means that the tip of the guidewire is distal to the target lesion, without dissection or perforation that limits blood flow).

E2. Life expectancy < 12 months.

E3. Any contraindication to the use of antiplatelet therapy and/or heparin

E4. Acute or subacute thrombosis in the target vessel.