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

Peripheral Artery Disease (PAD) Clinical Trial

— T3PROJECT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05665816
• Other study ID #: IMIB-STN-2022-02
• Status: Not yet recruiting
• Start date: January 15, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: December 2022
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: Jorge Cuenca Manteca, MD
• Phone: 968128600
• Email: jcuencam[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease (PAD)

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No device- or procedure-related mortality	Number of deaths	Up to 24 months.
Primary	No major amputation of the treated limb	Number of amputations	Up to 24 months.
Primary	No revascularization of the target lesion	Number of lesions not revascularized	Up to 24 months.
Primary	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	Serious Adverse Event Rates	Number of serious adverse events	Up to 24 months.
Secondary	Rate of success of the procedure	Number of Residual stenosis = 50% by visual estimation	Up to 24 months.
Secondary	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.
Secondary	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	Secondary patency.	Patency of the target lesion after treatment of a (re)occlusion of the target lesion.	Up to 24 months.
Secondary	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.
Secondary	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.
Secondary	Hemodynamic improvement	Ankle Brachial Index	Up to 24 months.
Secondary	Mortality from any cause	Number of deaths	Up to 24 months.