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

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

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%).

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease; Claudication
• Intervention / Treatment: Device: 4F portfolio products from Biotronik

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen
    • Bonheiden, Antwerpen, Belgium, 2820
      • Imelda Hospital
    • Edegem, Antwerpen, Belgium, 2650
      • Universitair Ziekenhuis Antwerpen
  • Oost-Vlaanderen
    • Dendermonde, Oost-Vlaanderen, Belgium, 9200
      • AZ Sint Blasius
• Germany
  • Leipzig, Germany, 04289
    • Park-Krankenhaus Leipzig
  • Münster, Germany, 48145
    • St Fransiskus hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: 4F portfolio products from Biotronik; 4F portfolio products from Biotronik: Astron pulsar / Astron Pulsar-18, Fortress, Passeo-18, Cruiser-18; Other Names: Astron pulsar; Astron Pulsar-18; Fortress; Passeo-18; Cruiser-18

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Flanders Medical Research Program
• Investigators: Principal Investigator: Marc Bosiers, MD, AZ Sint Blasius, Dendermonde, Belgium

Publications and helpful links

General Publications

• Bosiers M, Deloose K, Callaert J, Keirse K, Verbist J, Hendriks J, Lauwers P, D'Archambeau O, Scheinert D, Torsello G, Peeters P. 4-French-compatible endovascular material is safe and effective in the treatment of femoropopliteal occlusive disease: results of the 4-EVER trial. J Endovasc Ther. 2013 Dec;20(6):746-56. doi: 10.1583/13-4437MR.1.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 1, 2010
• First Submitted That Met QC Criteria: August 9, 2011
• First Posted (Estimate): August 10, 2011

Study Record Updates

• Last Update Posted (Estimate): October 1, 2013
• Last Update Submitted That Met QC Criteria: September 30, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: peripheral Vascular Disease; claudication; rest pain
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: FMRP-100701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No