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

be Medical435 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

435

Conditions

Peripheral Arterial Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Ziekenhuis Oost Limburg

Genk, Limburg, Belgium

University Hospital Leuven

Leuven, Vlaams Brabant, Belgium

Outcomes

Primary Outcomes

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.

Time frame: 12, 24 months

Secondary Outcomes

Secondary patency

Patency as defined by absence of \>50% restenosis , whether or not after additional intervention to maintain this patency

Time frame: 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

Time frame: 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

Time frame: 12 and 24 months

Limb-salvage rate

Time frame: 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.

Time frame: 12 and 24 months

Data from ClinicalTrials.gov

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