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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Peripheral Arterial Disease

Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rutherford category 2 - 5<br> | |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SFA, Stent, Atherosclerotic occlusive disease, Peripheral arterial disease, Superficial femoral artery