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

Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent to Treat Atherosclerotic Lesions 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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease

• Study Type: Observational
• Enrollment (Actual): 435

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Ziekenhuis Oost Limburg
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • University Hospital Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stenosis (> 75%) or occlusion of the superficial femoral artery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Rutherford category 2 - 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency	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.	12, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary patency	Patency as defined by absence of >50% restenosis , whether or not after additional intervention to maintain this patency	12 and 24 months
Target lesion revascularization	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	12 and 24 months
Target vessel revascularization	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	12 and 24 months
Limb-salvage rate		12 and 24 months
Clinical success rate	Clinical success rate defined asimprovement in symptoms according to the Rutherford classification by a minimum of 1 class.	12 and 24 months

Collaborators and Investigators

• Sponsor: be Medical
• Collaborators: Universitaire Ziekenhuizen KU Leuven; Ziekenhuis Oost-Limburg
• Investigators: Principal Investigator: Sabrina Houthoofd, MD, Universitaire Ziekenhuizen KU Leuven; Principal Investigator: Herman Schroë, MD, Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: April 21, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Peripheral arterial disease; Stent; SFA; Superficial femoral artery; Atherosclerotic occlusive disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: BM/BOSS 02-002