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

• ClinicalTrials.gov Identifier: NCT01413139
• Recruitment Status: Completed
• First Posted: August 10, 2011
• Last Update Posted: October 1, 2013
• Sponsor: Flanders Medical Research Program
• Information provided by (Responsible Party): Flanders Medical Research Program

Study Description

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%).

Condition or disease	Intervention/treatment	Phase
Peripheral Vascular Disease; Claudication	Device: 4F portfolio products from Biotronik	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 4-EVER Study - Physician-Initiated Trial Investigating the Safety of the Full 4F Endovascular Treatment Approach of Infra-Inguinal Arterial Stenotic Disease
• Study Start Date: July 2010
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: September 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 12 months ]
   Primary patency at 12 months, defined as freedom from >50% restenosis

Secondary Outcome Measures :

1. Technical success [ Time Frame: 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.
2. Puncture site complications [ Time Frame: 10 days ]
   Number of puncture site complications in the absence of a closure device after intervention
3. Primary patency [ Time Frame: 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.
4. Clinical success [ Time Frame: 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
5. Stent fracture rate at 12- & 24-month follow-up [ Time Frame: 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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Belgium

Imelda hospital

Bonheiden, Antwerpen, Belgium, 2820

Universitair ziekenhuis antwerpen

Edegem, Antwerpen, Belgium, 2650

AZ Sint Blasius

Dendermonde, Oost-Vlaanderen, Belgium, 9200

Germany

Park-Krankenhaus Leipzig

Leipzig, Germany, 04289

St Fransiskus hospital

Münster, Germany, 48145

Sponsors and Collaborators

Flanders Medical Research Program

Investigators

• Principal Investigator: Marc Bosiers, MD; AZ Sint Blasius, Dendermonde, Belgium

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Flanders Medical Research Program
• ClinicalTrials.gov Identifier: NCT01413139
• Other Study ID Numbers: FMRP-100701
• First Posted: August 10, 2011
• Last Update Posted: October 1, 2013
• Last Verified: September 2013

Keywords provided by Flanders Medical Research Program:

peripheral Vascular Disease; claudication; rest pain

Additional relevant MeSH terms:

Vascular Diseases; Intermittent Claudication; Peripheral Vascular Diseases; Peripheral Arterial Disease; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases