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

BE Medical

Status: Completed

Conditions: Peripheral Arterial Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01499342

BM/BOSS 02-002

Details and patient eligibility

About

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.

Enrollment: 435 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

435 participants in 1 patient group

Rutherford category 2 - 5