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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Universitaire Ziekenhuizen Leuven
Ziekenhuis Oost-Limburg
Information provided by:
be Medical
ClinicalTrials.gov Identifier:
NCT01499342
First received: April 21, 2011
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Peripheral Arterial Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by be Medical:

Primary Outcome Measures:
  • Primary patency [ Time Frame: 12, 24 months ] [ Designated as safety issue: No ]
    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:
  • Secondary patency [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    Patency as defined by absence of >50% restenosis , whether or not after additional intervention to maintain this patency

  • Target lesion revascularization [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    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

  • Target vessel revascularization [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    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

  • Limb-salvage rate [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Clinical success rate [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    Clinical success rate defined asimprovement in symptoms according to the Rutherford classification by a minimum of 1 class.


Estimated Enrollment: 500
Study Start Date: November 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rutherford category 2 - 5

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: be medical, Joris Coteur Study Coordinator
ClinicalTrials.gov Identifier: NCT01499342     History of Changes
Other Study ID Numbers: BM/BOSS 02-002
Study First Received: April 21, 2011
Last Updated: March 20, 2013
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013