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

NCT01413139 | Completed Phase 4

• 1 other identifier: FMRP-100701
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 5

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%).

Conditions

Peripheral Vascular Disease; Claudication

Keywords

peripheral Vascular Disease; claudication; rest pain

Outcome Measures

Primary Outcomes (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

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

  12 months

Secondary Outcomes (5)

• Technical success

  1 day post-procedure

• Puncture site complications

  10 days

• Primary patency

  6- & 24-month follow-up

• Clinical success

  6-, 12- & 24-month follow-up

• Stent fracture rate at 12- & 24-month follow-up

  12- & 24-month follow-up

Study Arms (1)

4F portfolio products from Biotronik

OTHER

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

Interventions

4F portfolio products from Biotronik DEVICE

4F portfolio products from Biotronik: Astron pulsar / Astron Pulsar-18, Fortress, Passeo-18, Cruiser-18

Also known as: Astron pulsar, Astron Pulsar-18, Fortress, Passeo-18, Cruiser-18

4F portfolio products from Biotronik

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (5)

Imelda hospital

Bonheiden, Antwerpen, 2820, Belgium

Location

Universitair ziekenhuis antwerpen

Edegem, Antwerpen, 2650, Belgium

Location

AZ Sint Blasius

Dendermonde, Oost-Vlaanderen, 9200, Belgium

Location

Park-Krankenhaus Leipzig

Leipzig, 04289, Germany

Location

St Fransiskus hospital

Münster, 48145, Germany

Location

Related Publications (1)

• 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.

  PMID: 24325689 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases; Intermittent Claudication

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Bosiers, MD

  AZ Sint Blasius, Dendermonde, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: August 10, 2011
• Study Start: July 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: September 1, 2013
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

BE (3); DE (2)