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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Flanders Medical Research Program
ClinicalTrials.gov Identifier:
NCT01413139
First received: July 1, 2010
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Peripheral Vascular Disease
Claudication
Device: 4F portfolio products from Biotronik
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Flanders Medical Research Program:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Primary patency at 12 months, defined as freedom from >50% restenosis


Secondary Outcome Measures:
  • Technical success [ Time Frame: 1 day post-procedure ] [ Designated as safety issue: No ]
    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.

  • Puncture site complications [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Number of puncture site complications in the absence of a closure device after intervention

  • Primary patency [ Time Frame: 6- & 24-month follow-up ] [ Designated as safety issue: No ]
    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.

  • Clinical success [ Time Frame: 6-, 12- & 24-month follow-up ] [ Designated as safety issue: No ]
    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

  • Stent fracture rate at 12- & 24-month follow-up [ Time Frame: 12- & 24-month follow-up ] [ Designated as safety issue: No ]

    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


Enrollment: 120
Study Start Date: July 2010
Study Completion Date: September 2013
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413139

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

No publications provided

Responsible Party: Flanders Medical Research Program
ClinicalTrials.gov Identifier: NCT01413139     History of Changes
Other Study ID Numbers: FMRP-100701
Study First Received: July 1, 2010
Last Updated: September 30, 2013
Health Authority: Belgium: Institutional Review Board
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Flanders Medical Research Program:
peripheral Vascular Disease
claudication
rest pain

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 17, 2014