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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Peripheral Artery Disease (PAD)

Intervention / Treatment
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* Device: Stent PULSAR® -18 T3,


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>Subjects with PAD treated with the PULSAR® -18 T3 Stent will be assessed for eligibility for the registry and consecutively included in the registry. Once informed consent is obtained, the required data will be collected. | Device: Stent PULSAR® -18 T3,<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No device- or procedure-related mortality | Number of deaths | Up to 24 months. | 
| No major amputation of the treated limb | Number of amputations | Up to 24 months. | 
| No revascularization of the target lesion | Number of lesions not revascularized | Up to 24 months. | 
| Revascularization rate of the clinically indicated target lesion | Number of new intervention of the target lesion, indicated by symptomatology or by a decrease in ABI (Ankle Brachial Index) ≥ 20% or ≥ 0.15 compared to the ABI after the index procedure or, a PSVR (Pick Systolic Velocity Ratio) > 2.4 measured by DUS (Doppler Ultrasound) | Up to 24 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Event Rates | Number of serious adverse events | Up to 24 months. | 
| Rate of success of the procedure | Number of Residual stenosis ≤ 50% by visual estimation | Up to 24 months. | 
| Primary patency | Absence of CD-TLR (clinically indicated TLR) and target lesion restenosis during follow-up, greater than 50% as determined by PSVR > 2.4 according to DUS (Doppler Ultrasound) | Up to 24 months. | 
| Assisted primary patency. | Patency of the target lesion after reoperation due to any reason, the lesion being patent at that time. | Up to 24 months. | 
| Secondary patency. | Patency of the target lesion after treatment of a (re)occlusion of the target lesion. | Up to 24 months. | 
| Rate of Clinical improvement (based on the Rutherford and WIfI classification) or absence of critical ischemia | Number of patients with maintained decrease of minus 1 degree in CR and exit from critical ischemia compared to baseline. | Up to 24 months. | 
| Rate of patients with major amputation of target limb | Number of surgical removal of the target limb: Supracondylar amputation: amputation of the limb with the resection point above the knee. Infracondylar amputation: amputation of the limb with the resection point below the knee. | Up to 24 months. | 
| Hemodynamic improvement | Ankle Brachial Index | Up to 24 months. | 
| Mortality from any cause | Number of deaths | Up to 24 months. |