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 (T3PROJECT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Artery Disease (PAD)
• Intervention / Treatment: Device: Stent PULSAR® -18 T3,

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jorge Cuenca Manteca, MD; Phone Number: 968128600; Email: jcuencam@gmail.com
• Study Contact Backup: Name: Maria Muñoz García; Phone Number: 968381290; Email: maria.munoz@imib.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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,; 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.

What is the study measuring?

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.
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.
Hemodynamic improvement	Ankle Brachial Index	Up to 24 months.
Mortality from any cause	Number of deaths	Up to 24 months.
Rate of success of the procedure	Number of Residual stenosis ≤ 50% by visual estimation	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.

Collaborators and Investigators

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Investigators: Principal Investigator: Jorge Cuenca Manteca, MD, Hospital Universitario Santa Lucía Murcia

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2023
• Primary Completion (Anticipated): January 15, 2024
• Study Completion (Anticipated): May 15, 2024

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 26, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: IMIB-STN-2022-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No