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.
Study Type
OBSERVATIONAL
Enrollment
100
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.
No device- or procedure-related mortality
Number of deaths
Time frame: Up to 24 months.
No major amputation of the treated limb
Number of amputations
Time frame: Up to 24 months.
No revascularization of the target lesion
Number of lesions not revascularized
Time frame: 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)
Time frame: Up to 24 months.
Serious Adverse Event Rates
Number of serious adverse events
Time frame: Up to 24 months.
Rate of success of the procedure
Number of Residual stenosis ≤ 50% by visual estimation
Time frame: 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)
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 24 months.
Secondary patency.
Patency of the target lesion after treatment of a (re)occlusion of the target lesion.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 months.
Hemodynamic improvement
Ankle Brachial Index
Time frame: Up to 24 months.
Mortality from any cause
Number of deaths
Time frame: Up to 24 months.