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

Peripheral Arterial Disease Clinical Trial

— BOSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499342
• Other study ID #: BM/BOSS 02-002
• Status: Completed
• Start date: November 2009
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: be Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost Limburg	Genk	Limburg
Belgium	University Hospital Leuven	Leuven	Vlaams Brabant

Sponsors (3)

Lead Sponsor	Collaborator
be Medical	Universitaire Ziekenhuizen Leuven, Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary patency	Patency as defined by absence of >50% restenosis , whether or not after additional intervention to maintain this patency	12 and 24 months
Secondary	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
Secondary	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
Secondary	Limb-salvage rate		12 and 24 months
Secondary	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