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Completed

NCT Number: NCT00496041

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

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.

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Key information

Conditions

Peripheral Vascular Disease Cardiovascular Diseases Constriction, Pathologic Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Registry

Procedure

A Registry will be used.

Primary outcomes

  1. Patency as defined by absence of occlusion or >50% restenosis rate at the level the treated lesion as determined by duplex control.

    Time frame: 1 year

Secondary outcomes

  1. Patency as defined by absence of occlusion, whether or not after additional intervention to maintain this patency (primary and secondary patency rate)

    Time frame: 1 year

  2. 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

    Time frame: 1 year

  3. 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.

    Time frame: 1 year

  4. Limbs-salvage rate

    Time frame: 1 year

  5. Clinical success rate defined on improvement in symptoms according to the Rutherford classification by a minimum of 1 class.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 4, 2007
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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