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

Flanders Medical Research Program

Status and phase

Completed

Phase 4

Conditions

Claudication

Peripheral Vascular Disease

Treatments

Device: 4F portfolio products from Biotronik

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01413139

FMRP-100701

Details and patient eligibility

About

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%).

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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