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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Flanders Medical Research Program

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 October 16, 2014