Trial document




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  DRKS00006281

Trial Description

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Title

A Prospective Study of the Performance of the Bard® LifeStent® Solo Vascular Stent System (REALITY2)

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Trial Acronym

REALITY2

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URL of the Trial

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Brief Summary in Lay Language

This study investigates the Bard LifeStent Solo Vascular System. The device is intended for patients who suffer from peripheral arterial disease (PAD). PAD is typically associated with a stenosis or occlusion of the lower limb arteries. The femoral artery and the popliteal artery are predominantly affected. PAD can reult in pain, walking impairment and wound healing deficiency. This study aims to collect data for deployment accuracy, safety, clinical utility and effectiveness of a stent length of 250 mm in order to support market authorization of the Bard LifeStent Solo Vasclular Stent System in the U.S.

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Brief Summary in Scientific Language

Singe-arm, non-randomized, prospective observational study of the Bard LifeStent Solo Vascular Stent System enrolling patients with a lifestyle-limiting intermitting claudication or minor tissue loss (Rutherford category 2-5) who are candidates for angioplasty (PTA) and stent therapy with lesions in the infra-inguinal segment (SFA and/or proximal popliteal artery). Patients will be treated with PTA and subsquent implantation of the Bard LifeStent Vascular Stent. The study aims to collect data of the deployment accuracy, safety, clinical utility and effectivenss of the Bard LifeStent Solo Vascular Stent in a length of 250 mm. This study aims to collect data for deployment accuracy, safety, clinical utility and effectiveness of a stent length of 250 mm in order to support PMA approval of the Bard LifeStent Solo Vasclular Stent System in the U.S.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006281
  •   2014/10/08
  •   2014/09/25
  •   no
  •   Approved
  •   323/14 (§23b MPG), Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   NCT02262949  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   I70.2 -  Atherosclerosis of arteries of extremities
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Interventions/Observational Groups

  •   Treatment with the Bard® LifeStent® Solo Vascular Stent System (250 mm stent length)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Safety: Freedom from occurrence of death, amputation and TLR (Target Lesion Revascularization)/TVR (Target Vessel Revascularization) at 30 days post-index procedure.
Effectiveness: Stent deployment success and accuracy.

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Secondary Outcome

Safety: Freedom from death (after 30 days), stroke, MI (myocardial infarction), emergent surgical revascularization of the target limb, significant distal embolization in target limb, target limb major amputation, and thrombosis of target vessel at 12 months post-index procedure.

Effectiveness: Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) after 30 days, 6 and 12 months post-index procedure.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/10/01
  •   30
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   21   Years
  •   no maximum age
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Additional Inclusion Criteria

1. The subject or legal representative has been informed of the nature of the evaluation, agrees to its provisions, and has signed the informed consent form (ICF). 2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits. 3. The subject is 21 years old. 4. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within seven days prior to index procedure. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test. 5. The subject has lifestyle-limiting claudication or minor tissue loss defined as: Rutherford Category 2-5 (moderate claudication to minor tissue loss). 6. The target lesion(s) has angiographic evidence of stenosis or restenosis 50% or occlusion of the SFA and/or popliteal artery (by visual estimate) and is amenable to PTA and stenting. 7. There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).

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Exclusion Criteria

1. The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study follow-up procedure and visits. 2. The subject has claudication or critical limb ischemia described as Rutherford Category 0 (asymptomatic), 1 ( mild claudication), or 6 (major tissue loss). 3. The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medications, nickel, titanium or tantalum. 4. The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines. 5. The subject has a history of bleeding diatheses or coagulopathy. 6. The subject has concomitant renal failure with a creatinine of >2.5 mg/dL. 7. The subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure. 8. The subject is receiving dialysis or immunosuppressive therapy. 9. The subject is participating in an investigational drug or another investigational device study. 10. The subject has another medical condition, which, in the opinion of the investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of less than two years. 11. The subject has extensive peripheral vascular disease, which, in the opinion of the investigator, precludes safe insertion of an introducer sheath. 12. The target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s). 13. The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft. 14. The subject is diagnosed with septicemia at the time of the study procedure. 15. Patients with a stent previously implanted into the target vessel. 16. Lesions requiring the use of more than one investigational stent. 17. Bilateral disease in the native SFA and/or proximal popliteal artery where both limbs meet the inclusion/exclusion criteria and it is planned to treat both limbs within 30 days.

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Addresses

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    • Bard Peripheral Vascular, Inc.
    • 1625 West 3rd Street
    • 85281  Tempe/AZ
    • United States
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    • Universitäts-Herzzentrum Freiburg, Bad Krozingen
    • Mr.  Prof. Dr. med.  Thomas  Zeller 
    • Südring 15
    • 79189   Bad Krozingen
    • Germany
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    • Universitäts-Herzzentrum Freiburg, Bad Krozingen
    • Mr.  Prof. Dr. med.  Thomas  Zeller 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
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Sources of Monetary or Material Support

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    • Bard Peripheral Vascular, Inc.
    • 1625 West 3rd Street
    • 85281  Tempe/AZ
    • United States
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Status

  •   Recruiting complete, follow-up complete
  •   2016/06/24
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Trial Publications, Results and other Documents

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