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NCT00496041 Clinical Trial

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

Peripheral Vascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00496041
Other study ID # 2007/208
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2007
Est. completion date December 31, 2008

Study information
Verified date March 2023
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 205
Est. completion date December 31, 2008
Est. primary completion date December 31, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Registry
A Registry will be used.

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Patency as defined by absence of occlusion, whether or not after additional intervention to maintain this patency (primary and secondary patency rate) 1 year
Secondary 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
Secondary 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
Secondary Limbs-salvage rate 1 year
Secondary Clinical success rate defined on improvement in symptoms according to the Rutherford classification by a minimum of 1 class. 1 year
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