Remedy, Biodegradable Peripheral Stent Registry

Study Overview
=================
Brief Summary
-----------------
This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries. Patients will be followed for a period of 1 year.

Official Title
-----------------
A Prospective Multicenter Registry to Evaluate Safety and Performance of REMEDY, Biodegradable Peripheral Stent for the Treatment of Occluded or Stenotic Superficial Femoral Arteries.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic leg ischemia requiring treatment of SFA artery or proximal popliteal artery located within the following parameters: 1 cm from the femoral bifurcation in the SFA 3 cm from the proximal margin of the intercondylar fossa Rutherford-Becker Category 2-5. In patients with bilateral lesions, the highest Rutherford Category limb should be treated. Only 1 leg can be included. Single lesion which can be covered by one stent. Target vessel reference diameter ≥ 4 mm and ≤ 6 mm (by visual estimate) A patent popliteal artery free from significant stenosis (>50%) with at least one patent vessel runoff as confirmed by baseline angiography Signed informed consent. Exclusion Criteria: Pregnancy Previous stenting of target lesion Acute ischemia Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion). Inclusion of a patient is allowed in case inflow lesions are successfully treated during the index-procedure yielding less than 30% diameter stenosis. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy Known intolerance to study medications or contrast agents.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of clinically driven target lesion revascularization at 12 months. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Defined as a successful access and deployment of the device and determined by less than 30% residual stenosis by angiography at the baseline procedure. | During procedure | 
| Clinical success | Defined as technical success without the occurrence of serious adverse events during procedure | During procedure | 
| Primary and secondary patency rate | defined as < 50% diameter reduction and peak systolic velocity < 2.4 at 12 months. | 12 months | 
| Ankle-Brachial Index improvement of ≥ 0.1 |  | 1, 6 and 12 months | 
| Clinically driven target vessel revascularization |  | 6 and 12 months | 
| Major complications at 6 and 12 months, including amputation of a part of the foot, the leg below and above the knee. |  | 6 and 12 months | 
| Rutherford-Becker classification of chronic limb ischemia |  | 1, 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biodegradable stent, PAD