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

University Hospital, Ghent205 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

205

Conditions

Peripheral Vascular Disease

Interventions

RegistryPROCEDURE

A Registry will be used.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Ghent

Ghent, Belgium

Outcomes

Primary Outcomes

Patency as defined by absence of occlusion or >50% restenosis rate at the level the treated lesion as determined by duplex control.

Time frame: 1 year

Secondary Outcomes

Patency as defined by absence of occlusion, whether or not after additional intervention to maintain this patency (primary and secondary patency rate)

Time frame: 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

Time frame: 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.

Time frame: 1 year

Limbs-salvage rate

Time frame: 1 year

Clinical success rate defined on improvement in symptoms according to the Rutherford classification by a minimum of 1 class.

Time frame: 1 year

Data from ClinicalTrials.gov

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