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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00496041

Enrollment

205

Registered

2007-07-04

Start date

2007-07-31

Completion date

2008-12-31

Last updated

2023-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Vascular Disease

Keywords

Stenosis (> 75%) or occlusion of the superficial femoral artery

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.

Interventions

PROCEDURERegistry

A Registry will be used.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026