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NCT05665816
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: Peripheral Artery Disease (PAD)
Sex: All
Ages: 55 Years – N/A
Enrollment: 100
Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Summary
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.
Eligibility Criteria
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 heparinE4. Acute or subacute thrombosis in the target vessel.
Source: ClinicalTrials.gov (NCT05665816). StuddyBuddy aggregates publicly available trial information.