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

This study has been completed.
Sponsor:
Collaborators:
Universitaire Ziekenhuizen Leuven
Ziekenhuis Oost-Limburg
Information provided by:
be Medical
ClinicalTrials.gov Identifier:
NCT01499342
First received: April 21, 2011
Last updated: May 13, 2014
Last verified: May 2014
  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:


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
Study Completion Date: February 2014
Primary Completion Date: February 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 13, 2014
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 July 23, 2014