Peripheral Artery Disease (PAD)
Conditions
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.
Interventions
DEVICEStent 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.
Sponsors
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| No major amputation of the treated limb | Up to 24 months. | Number of amputations |
| No revascularization of the target lesion | Up to 24 months. | Number of lesions not revascularized |
| No device- or procedure-related mortality | Up to 24 months. | Number of deaths |
| Revascularization rate of the clinically indicated target lesion | Up to 24 months. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assisted primary patency. | Up to 24 months. | Patency of the target lesion after reoperation due to any reason, the lesion being patent at that time. |
| Secondary patency. | Up to 24 months. | Patency of the target lesion after treatment of a (re)occlusion of the target lesion. |
| Rate of Clinical improvement (based on the Rutherford and WIfI classification) or absence of critical ischemia | Up to 24 months. | Number of patients with maintained decrease of minus 1 degree in CR and exit from critical ischemia compared to baseline. |
| Rate of patients with major amputation of target limb | Up to 24 months. | 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. |
| Hemodynamic improvement | Up to 24 months. | Ankle Brachial Index |
| Mortality from any cause | Up to 24 months. | Number of deaths |
| Serious Adverse Event Rates | Up to 24 months. | Number of serious adverse events |
| Rate of success of the procedure | Up to 24 months. | Number of Residual stenosis ≤ 50% by visual estimation |
| Primary patency | Up to 24 months. | 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) |
Contacts
Primary ContactJorge Cuenca Manteca, MD
Backup ContactMaria Muñoz García
Outcome results
None listed