An observational study in Peripheral Artery Disease (PAD), sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. Status unknown. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2022-12-29.
Sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Observational
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.
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's planned enrollment of 100 is below the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia is the lead sponsor of 42 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
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.
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.
No device- or procedure-related mortality
Number of deaths
Time frame: Up to 24 months.
No major amputation of the treated limb
Number of amputations
Time frame: Up to 24 months.
No revascularization of the target lesion
Number of lesions not revascularized
Time frame: 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)
Time frame: Up to 24 months.
Serious Adverse Event Rates
Number of serious adverse events
Time frame: Up to 24 months.
Rate of success of the procedure
Number of Residual stenosis ≤ 50% by visual estimation
Time frame: 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)
Time frame: 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.
Time frame: Up to 24 months.
Secondary patency.
Patency of the target lesion after treatment of a (re)occlusion of the target lesion.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 months.
Hemodynamic improvement
Ankle Brachial Index
Time frame: Up to 24 months.
Mortality from any cause
Number of deaths
Time frame: Up to 24 months.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia