CompletedNot Applicable

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

Belgium205 participantsStarted 2007-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 1 year

Trial details

NCT IDNCT00496041

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-12-31

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