4-EVER : a Trial Investigating the Safety of 4F Endovascular Treatment of Infra-Inguinal Arterial Stenotic Disease

Study Overview
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Brief Summary
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The objective of this clinical investigation is to evaluate puncture site complication rate as well as the short- and long-term (up to 24 months) outcome of treatment by means of Astron Pulsar / Astron Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions, using 4F compatible devices of BIOTRONIK and without the use of a closure device. The hypothesis is that the primary patency at 12 months is non-inferior to the primary patency obtained in the Durability study (72.2%).

Official Title
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4-EVER Study - Physician-Initiated Trial Investigating the Safety of the Full 4F Endovascular Treatment Approach of Infra-Inguinal Arterial Stenotic Disease

Conditions
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Peripheral Vascular Disease, Claudication

Intervention / Treatment
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* Device: 4F portfolio products from Biotronik


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: De novo, restenotic or reoccluded lesion located in the femoropopliteal arteries suitable for endovascular treatment Patient presenting with a score from 2 to 4 according to the Rutherford classification Patient is willing to comply with specified follow-up evaluations at the predefined time intervals times Patient is >18 years old Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study Prior to enrollment, the target lesion was crossed with standard guidewire manipulation Patient is eligible for treatment with 4F compatible devices Angiographic Inclusion Criteria: The target lesions are located within the native superficial femoral artery: Distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis. The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion Length of the target lesion is =20 cm by visual estimation and can be covered with one stent Target vessel diameter visually estimated is =4 mm and =6.5 mm There is angiographic evidence of at least one-vessel-runoff to the foot Exclusion Criteria: Presence of another stent in the target vessel that was placed during a previous procedure Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis Previous bypass surgery in the same limb Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics Patients who exhibit persistent acute intraluminal thrombus at the target lesion site Perforation at the angioplasty site evidenced by extravasation of contrast medium Patients with known hypersensitivity to nickel-titanium Patients with uncorrected bleeding disorders Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding Life expectancy of less than 12 months Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis > 30% Use of thrombectomy, atherectomy or laser devices during procedure Any planned surgical intervention/procedure 30 days after the study 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 reached the primary endpoint

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 4F portfolio products from Biotronik<br>The devices under investigation are the 4F portfolio products from Biotronik: Astron pulsar / Astron Pulsar-18, Fortress, Passeo-18 and Cruiser-18. | Device: 4F portfolio products from Biotronik<br>* 4F portfolio products from Biotronik: Astron pulsar / Astron Pulsar-18, Fortress, Passeo-18, Cruiser-18<br>* Other names: Cruiser-18;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency at 12 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention | Primary patency at 12 months, defined as freedom from >50% restenosis | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Technical success, defined as the ability to cross and stent the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging. | 1 day post-procedure | 
| Puncture site complications | Number of puncture site complications in the absence of a closure device after intervention | 10 days | 
| Primary patency | Primary patency rate at 6- & 24-month follow-up, defined as freedom from >50% restenosis at 6 & 24 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention. | 6- & 24-month follow-up | 
| Clinical success | Clinical success at follow-up is defined as an improvement of Rutherford classification at 6-, 12- & 24-month follow-up of one class or more as compared to the pre-procedure | 6-, 12- & 24-month follow-up | 
| Stent fracture rate at 12- & 24-month follow-up | Stent fracture rate at 12- & 24-month follow-up (in patient who were treated with stentplacement), as determined according the following classification on x-ray: Class 0 : no strut factures Class I : single tine fracture Class II : multiple tine factures Class III : Stent fracture(s) with preserved alignment of the components Class IV : Stent fracture(s) with mal-alignment of the components Class V : Stent fracture(s) in a trans-axial spiral configuration | 12- & 24-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral Vascular Disease, claudication, rest pain