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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

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

External Links

•   Website of the University Hospital Ghent