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Completed

NCT Number: NCT01499342

Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent in the Superficial Femoral Artery

This is a Belgian prospective multicentre registry to evaluate safety and performance of the Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic lesions. Target number is 500 patients in approximately 11 centres. Patients will be followed for a period of 2 years.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuis Oost Limburg, Genk, Limburg, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent
  • Stenosis (> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal and 4 cm proximal to the patella)
  • TASC II (2007)type A, B or C lesions
  • Target vessel diameter between 4.5 and 7 mm
  • Debilitating claudication or critical limb ischemia (Rutherford 2 to 5)
  • At least 1 outflow vessel down to the ankle
  • Patient is at least 18 years old
  • Life expectancy > 2 years
  • Patient is compliant with the requested follow-up visits

Exclusion criteria

  • No informed consent
  • Rutherford 6
  • TASC II type D lesions
  • Patient is not 18 years old
  • Patient is pregnant
  • Acute ischemia
  • Patient is not compliant with the requested follow-up visits
  • Unable to cross target lesion with guidewire
  • Patient is allergic to nickel-titanium
  • Presence of an aneurysm in the SFA

Treatment and study plan

Primary outcomes

  1. Primary patency

    Time frame: 12, 24 months

    Primary patency rate at 12 and 24 months as determined by Duplex ultrasound, defined as <50% diameter restenosis(systolic velocity ratio no greater than 2.4) at the level of the treated lesion, without occurrence of target lesion revasularization between the index-procedure and the 12 and 24 months follow-up.

Secondary outcomes

  1. Secondary patency

    Time frame: 12 and 24 months

    Patency as defined by absence of >50% restenosis , whether or not after additional intervention to maintain this patency

  2. Target lesion revascularization

    Time frame: 12 and 24 months

    Target lesion revascularisation rate as defined by the number of new revascularizations (endovascular or surgery) carried out due to restenosis or thrombosis at the level of the stented lesion

  3. Target vessel revascularization

    Time frame: 12 and 24 months

    Target vessel revascularization rate as defined by the number of new revascularizations (endovascular or surgery) carried out due to restenosis or a new stenosis in the SFA

  4. Limb-salvage rate

    Time frame: 12 and 24 months

  5. Clinical success rate

    Time frame: 12 and 24 months

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

Sponsors and collaborators

Lead sponsor

be Medical

Industry

Collaborators

  • Universitaire Ziekenhuizen KU Leuven
  • Ziekenhuis Oost-Limburg

Registry information

Official study title

Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent to Treat Atherosclerotic Lesions in the Superficial Femoral Artery

Acronym: BOSS

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Dec 26, 2011
Registry last updated
Aug 22, 2022

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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