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

Phase 4

Completed

• Conditions: Peripheral Vascular Disease; Claudication
• Interventions: Device: 4F portfolio products from Biotronik

• Registration Number: NCT01413139
• Lead Sponsor: Flanders Medical Research Program

Brief Summary

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%).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-01
• Primary Completion: 2011-05
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Status Verified: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-30
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4F portfolio products from Biotronik	4F portfolio products from Biotronik	The devices under investigation are the 4F portfolio products from Biotronik: Astron pulsar / Astron Pulsar-18, Fortress, Passeo-18 and Cruiser-18.

Primary Outcome Measures

Name	Time	Method
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	12 months	Primary patency at 12 months, defined as freedom from \>50% restenosis

Secondary Outcome Measures

Name	Time	Method
Primary patency	6- & 24-month follow-up	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.
Clinical success	6-, 12- & 24-month follow-up	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
Stent fracture rate at 12- & 24-month follow-up	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: 1. Class 0 : no strut factures; 2. Class I : single tine fracture; 3. Class II : multiple tine factures; 4. Class III : Stent fracture(s) with preserved alignment of the components; 5. Class IV : Stent fracture(s) with mal-alignment of the components; 6. Class V : Stent fracture(s) in a trans-axial spiral configuration
Technical success	1 day post-procedure	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.
Puncture site complications	10 days	Number of puncture site complications in the absence of a closure device after intervention

Trial Locations

Locations (5)

Imelda hospital; 🇧🇪 Bonheiden, Antwerpen, Belgium

Universitair ziekenhuis antwerpen; 🇧🇪 Edegem, Antwerpen, Belgium

St Fransiskus hospital; 🇩🇪 Münster, Germany

Park-Krankenhaus Leipzig; 🇩🇪 Leipzig, Germany

AZ Sint Blasius; 🇧🇪 Dendermonde, Oost-Vlaanderen, Belgium