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

Not Applicable

Completed

• Conditions: Peripheral Vascular Disease
• Interventions: Procedure: Registry

• Registration Number: NCT00496041
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Primary Completion: 2008-12-31
• Study Completion: 2008-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Smart Stent in the Superficial Femoral Artery .	Registry	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical success rate defined on improvement in symptoms according to the Rutherford classification by a minimum of 1 class.	1 year
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 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
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
Limbs-salvage rate	1 year

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium