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

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ClinicalTrials.gov Identifier: NCT01413139
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : October 1, 2013
Sponsor:
Information provided by (Responsible Party):
Flanders Medical Research Program

Tracking Information
First Submitted Date  ICMJE July 1, 2010
First Posted Date  ICMJE August 10, 2011
Last Update Posted Date October 1, 2013
Study Start Date  ICMJE July 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2011)
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 ]
Primary patency at 12 months, defined as freedom from >50% restenosis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2013)
  • Technical success [ Time Frame: 1 day post-procedure ]
    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 ]
    Number of puncture site complications in the absence of a closure device after intervention
  • Primary patency [ Time Frame: 6- & 24-month follow-up ]
    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 ]
    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 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2011)
  • Technical success [ Time Frame: procedure (day 0) ]
    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 ]
    Number of puncture site complications in the absence of a closure device after intervention
  • Primary patency [ Time Frame: 6- & 24-month follow-up ]
    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 ]
    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 ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 4-EVER : a Trial Investigating the Safety of 4F Endovascular Treatment of Infra-Inguinal Arterial Stenotic Disease
Official Title  ICMJE 4-EVER Study - Physician-Initiated Trial Investigating the Safety of the Full 4F Endovascular Treatment Approach of Infra-Inguinal Arterial Stenotic Disease
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%).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral Vascular Disease
  • Claudication
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Device: 4F portfolio products from Biotronik
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2011)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01413139
Other Study ID Numbers  ICMJE FMRP-100701
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Flanders Medical Research Program
Study Sponsor  ICMJE Flanders Medical Research Program
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc Bosiers, MD AZ Sint Blasius, Dendermonde, Belgium
PRS Account Flanders Medical Research Program
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP