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

NCT05665816 | Unknown

• 1 other identifier: IMIB-STN-2022-02
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Artery Disease (PAD)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Serious Adverse Event Rates

  Up to 24 months.

• Rate of success of the procedure

  Up to 24 months.

• Primary patency

  Up to 24 months.

• Assisted primary patency.

  Up to 24 months.

• Secondary patency.

  Up to 24 months.

Study Arms (1)

Intervention

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,

Interventions

Stent PULSAR® -18 T3, DEVICE

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.

Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Jorge Cuenca Manteca, MD

  Hospital Universitario Santa Lucía Murcia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Cuenca Manteca, MD

CONTACT

968128600; jcuencam@gmail.com

Maria Muñoz García

CONTACT

968381290; maria.munoz@imib.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: December 27, 2022
• Study Start: January 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: May 15, 2024
• Last Updated: December 29, 2022

Record last verified: 2022-12