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

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ClinicalTrials.gov Identifier: NCT01499342
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : May 14, 2014
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease
Peripheral Arterial Disease

Study Design

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent to Treat Atherosclerotic Lesions in the Superficial Femoral Artery
Study Start Date : November 2009
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Rutherford category 2 - 5


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stenosis (> 75%) or occlusion of the superficial femoral artery.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01499342


Locations
Belgium
Ziekenhuis Oost Limburg
Genk, Limburg, Belgium, 3600
University Hospital Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Sponsors and Collaborators
be Medical
Universitaire Ziekenhuizen Leuven
Ziekenhuis Oost-Limburg
Investigators
Principal Investigator: Sabrina Houthoofd, MD Universitaire Ziekenhuizen Leuven
Principal Investigator: Herman Schroë, MD Ziekenhuis Oost-Limburg
More Information

Responsible Party: be medical, Joris Coteur Study Coordinator
ClinicalTrials.gov Identifier: NCT01499342     History of Changes
Other Study ID Numbers: BM/BOSS 02-002
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014

Keywords provided by be Medical:
Stent
Atherosclerotic occlusive disease
Peripheral arterial disease
Superficial femoral artery
SFA

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases