DURABILITY+ : a Prospective, Multi-center, Controlled Study With the Everflex+ Stent in SFA Lesions

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the immediate and long-term (up to 12 months) safety and effectiveness of primary stenting with the Protégé Everflex+ stent system for the treatment of superficial femoral artery (SFA) lesions (without involvement of the popliteal artery) between 40 mm and 180 mm in length.

Official Title
-----------------
DURABILITY+ : a Prospective, Multi-center, Controlled Study Measuring the Durability in Lesions of the Superficial Femoral Artery of the Protégé Everflex+ Stent

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

Intervention / Treatment
-----------------
* Device: stent placement


Participation Criteria
=================
Eligibility Criteria
-----------------
General Inclusion Criteria: De novo, restenotic or reoccluded (from PTA or adjunct therapy, not including stents or stent grafts) lesion located in the superficial femoral artery (without popliteal involvement) with proximal point at least one centimeter below the origin of the profunda femoralis and suitable for stenting Patient presenting with a score from 2 to 4 following Rutherford classification Patient is willing to comply with specified follow-up evaluations at the specified times Patient is >18 years old Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrollment in the study Angiographic Inclusion Criteria The length of the target lesion is minimally 40 mm and maximally 180 mm, to be covered with one stent The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation Target vessel diameter visually estimated is >3.5 mm and <7.5 mm Prior to enrollment, the guidewire has crossed target lesion There is angiographic evidence of at least one-vessel-runoff to the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention Patient is eligible for treatment with the Protégé Everflex+ stent system General Exclusion Criteria: Presence of another stent or stent graft in the target vessel that was placed during a previous procedure Previous by-pass surgery in the same limb requiring access to the target lesion Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated or no alternative is available Patients with known hypersensitivity to nickel-titanium Patients with uncorrected bleeding disorders Female patient with child bearing potential not using adequate contraceptives or currently breastfeeding Life expectancy of less than twelve months Use of thrombectomy, artherectomy, cryoplasty, cutting balloon, drug-eluting balloon, embolic protection or laser devices during procedure Any patient considered to be hemodynamically unstable at onset of procedure Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period. Angiographic Exclusion Criteria Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis Patients who exhibit persistent acute intraluminal thrombus of the proposed target lesion site Perforation, dissection or other injury of the access site or target vessel requiring additional stenting or surgical intervention prior to start of the index procedure Perforation at the angioplasty site evidenced by extravasation of contrast medium Aneurysm located at the level of the SFA and/or proximal popliteal

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protégé EverFlex+<br>Stenting with Protégé EverFlex+ | Device: stent placement<br>* pre-dilation of the study lesion is mandatory stent placement with 1 Protégé Everflex+ stent only 1 stent is allowed within the study protocol post-dilation may be performed but is not mandatory<br>* Other names: Protégé EverFlex+;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Event rate | The primary safety endpoint of the study is the Major Adverse Event (MAE) rate at 30 days. MAE is defined as: clinically-driven target lesion revascularization, amputation of treated limb or all-cause mortality through 30 days post procedure. | 30 days post-procedure | 
| Primary stent patency | The primary effectiveness endpoint of the study is primary stent patency at 12 months. Primary patency is defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months. | 12 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Technical success, defined as the ability to cross and stent the lesion, after predilation, and with or without additional post-dilation, and achieve residual angiographic stenosis no greater than 30% | 1 day post-procedure | 
| Primary stent patency at 1 and 6 months | Primary patency at 1, 6 months. Primary patency is defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within the time of procedure and the given follow-up. | 1 and 6 months post-procedure | 
| Primary assisted patency | Primary assisted patency rate at 1, 6, 12-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure. | 1, 6 and 12 months post-procedure | 
| Secondary patency | Secondary patency rate at 1, 6, 12-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion. | 1, 6 and 12 months post-procedure | 
| Target lesion revascularization | Target lesion revascularization (TLR) is defined as a repeat intervention, within the study follow-up period of 12 months, to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge. | 12 months post-procedure | 
| limb-salvage | Limb-salvage rate at all follow-up visits for the subgroup of patients with critical limb ischemia (Rutherford category 4), defined as absence of major amputation. Major amputation is defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot) | 12-months post-procedure | 
| Clinical success | Clinical success at follow-up, defined as an improvement of Rutherford classification at 1 day and 1, 6, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification | 1, 6 and 12 months post-procedure | 
| Serious adverse events | Serious adverse events defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization. | 12-months post-procedure |