Clinical trial NCT01413139: 4-EVER : a Trial Investigating the Safety of 4F Endovascular Treatment of Infra-Inguinal Arterial Stenotic Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Vascular Disease
Claudication
Keywords: peripheral Vascular Disease
claudication
rest pain
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
First posted: 2011-08-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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%).


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Technical success
timeFrame: 1 day post-procedure
measure: Puncture site complications
timeFrame: 10 days
measure: Primary patency
timeFrame: 6- & 24-month follow-up
measure: Clinical success
timeFrame: 6-, 12- & 24-month follow-up
measure: Stent fracture rate at 12- & 24-month follow-up
timeFrame: 12- & 24-month follow-up
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda hospital
state: Antwerpen
city: Edegem
country: Belgium
facility: Universitair ziekenhuis antwerpen
state: Antwerpen
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius
state: Oost-Vlaanderen
city: Leipzig
country: Germany
facility: Park-Krankenhaus Leipzig
city: Münster
country: Germany
facility: St Fransiskus hospital
Study officials:
affiliation: AZ Sint Blasius, Dendermonde, Belgium
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.