Clinical trial 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
Official title: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Artery Disease (PAD)
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the statistical analyzes will be carried out in the group of patients who have the necessary data to evaluate the main objective. Secondary objectives will be analyzed using available data only (missing data imputation techniques will not be used).

Brief 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.

Detailed description: 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.

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 heparin

E4. Acute or subacute thrombosis in the target vessel.

Primary outcomes:
measure: No device- or procedure-related mortality
timeFrame: Up to 24 months.
measure: No major amputation of the treated limb
timeFrame: Up to 24 months.
measure: No revascularization of the target lesion
timeFrame: Up to 24 months.
measure: Revascularization rate of the clinically indicated target lesion
timeFrame: Up to 24 months.
Secondary outcomes:
measure: Serious Adverse Event Rates
timeFrame: Up to 24 months.
measure: Rate of success of the procedure
timeFrame: Up to 24 months.
measure: Primary patency
timeFrame: Up to 24 months.
measure: Assisted primary patency.
timeFrame: Up to 24 months.
measure: Secondary patency.
timeFrame: Up to 24 months.
measure: Rate of Clinical improvement (based on the Rutherford and WIfI classification) or absence of critical ischemia
timeFrame: Up to 24 months.
measure: Rate of patients with major amputation of target limb
timeFrame: Up to 24 months.
measure: Hemodynamic improvement
timeFrame: Up to 24 months.
measure: Mortality from any cause
timeFrame: Up to 24 months.
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario Santa Lucía Murcia
name: Jorge Cuenca Manteca, MD
role: PRINCIPAL_INVESTIGATOR
References: