Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-classification

Study Overview
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Brief Summary
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This is a Belgian prospective multicentre registry on the performance of the Smart stent in the superficial femoral artery according to the new tasc II-classification.

Official Title
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Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-classification

Conditions
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Peripheral Vascular Disease

Intervention / Treatment
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* Procedure: Registry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stenosis (> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal) New TASC (2007) A, B, or C lesions Vessel diameter between 4.5 and 6.5 cm Debilitating claudication or critical limb ischemia (Rutherford 2 to 5) At least 1 outflow vessel down to the ankle Signed informed consent > Age 50, life expectancy > 1 year Capable of concluding the necessary follow-up visits Exclusion Criteria: Refusal to participate in the study Acute ischemia Inflow lesions > 50%, not successfully corrected before the procedure Combination with other treatment with the exception of treatment to improve the inflow

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart Stent in the Superficial Femoral Artery .<br> | Procedure: Registry<br>* A Registry will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency as defined by absence of occlusion or >50% restenosis rate at the level the treated lesion as determined by duplex control. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency as defined by absence of occlusion, whether or not after additional intervention to maintain this patency (primary and secondary patency rate) |  | 1 year | 
| Target lesion revascularisation rate as defined by the number of new revascularisations (endovascular or open) carried out due to restenosis at the level of the stented lesion |  | 1 year | 
| Target vessel revascularisation rate as defined by the number of new revascularisations (endovascular or open) carried out due to restenosis or a new stenosis in the SFA. |  | 1 year | 
| Limbs-salvage rate |  | 1 year | 
| Clinical success rate defined on improvement in symptoms according to the Rutherford classification by a minimum of 1 class. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stenosis (> 75%) or occlusion of the superficial femoral artery