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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Peripheral Vascular Disease

Treatments: Procedure: Registry

Study type: Interventional

Funder types: Other

Identifiers

NCT00496041

2007/208

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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205 participants in 1 patient group

Smart Stent in the Superficial Femoral Artery .

Experimental group

Treatment:

Procedure: Registry