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

Peripheral Vascular Disease Clinical Trial

— 4-EVER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413139
• Other study ID #: FMRP-100701
• Status: Completed
• Phase: Phase 4
• First received: July 1, 2010
• Last updated: September 30, 2013
• Start date: July 2010
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Flanders Medical Research Program
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2013
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Belgium	Imelda hospital	Bonheiden	Antwerpen
Belgium	AZ Sint Blasius	Dendermonde	Oost-Vlaanderen
Belgium	Universitair ziekenhuis antwerpen	Edegem	Antwerpen
Germany	Park-Krankenhaus Leipzig	Leipzig
Germany	St Fransiskus hospital	Münster

Sponsors (1)

Lead Sponsor	Collaborator
Flanders Medical Research Program

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Puncture site complications	Number of puncture site complications in the absence of a closure device after intervention	10 days	No
Secondary	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	No
Secondary	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	No
Secondary	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	No