Trial document




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  DRKS00005198

Trial Description

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Title

A Prospective Study of the Performance of the Bard® LifeStent® Vascular Stent Systems (REALITY)

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Trial Acronym

REALITY

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The device being surveyed in this study is the Bard® LifeStent® Vascular Stent System. It is intended for use in patients who suffer from peripheral artery disease (PAD). PAD is generally associated with blocked arteries of the legs. The SFA and popliteal artery are common locations for this problem to develop. Pain or discomfort may be experienced in the leg that occurs when walking or other complications associated with wound healing.
The purpose of this study is to collect information to assess the clinical utility and effectiveness of the 5 mm diameter size offering of the device in order to support authority approval of the Bard® LifeStent® Vascular Stent System in the USA.

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Brief Summary in Scientific Language

The study is a single-arm, non-randomized, prospective, observational study with the Bard® LifeStent® Vascular Stent in subjects with lifestyle-limiting claudication or minor tissue loss (Rutherford category 2-5) who are candidates for PTA and stenting with lesion(s) in the infra-inguinal segment (SFA and/or popliteal artery). Subjects will be treated with PTA followed by implantation of the Bard® LifeStent® Vascular Stent.
The purpose of this study is to assess the deliverability, clinical utility and effectiveness of the 5mm diameter size offering of the LifeStent® Vascular Stent in order to support FDA approval of a PMA supplement.

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Organizational Data

  •   DRKS00005198
  •   2013/08/13
  •   2013/08/07
  •   no
  •   Approved
  •   267/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   NCT01920308  (ClinicalTrials.gov)
  •   [---]*  (Bard Peripheral Vascular, Inc.)
  •   [---]* 
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Health Condition or Problem studied

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

  •   Subjects will be treated with PTA followed by implantation of the Bard® LifeStent® Vascular Stent.
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Characteristics

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

Safety: Freedom from occurrence of death, amputation and TLR/TVR at 30 days post-index procedure. 30 day data can be collected via telephone screening. TLR is defined as a revascularization procedure (e.g. PTA, cryoplasty, etc.) of the target lesion. TVR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) of the target vessel outside the target lesion. Effectiveness: Technical success, defined as successful deployment and placement accuracy based upon a rating scale completed by the investigators at time of index procedure. Bookend sizes will be evaluated for clinical utility of size range.

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Secondary Outcome

Secondary Safety: Freedom from death (after 30 days), stroke, MI, emergent surgical revascularization, 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. TLR is defined as a revascularization procedure (e.g., PTA, cryoplasty, etc.) of the target lesion. TVR is defined as a revascularization procedure (e.g., PTA, stenting, surgical bypass, etc.) of the target vessel outside the target lesion. 6* and 12 Month Primary Patency Rates: - A reduction in luminal diameter of ≤ 50% and of ≤ 70% measured by Duplex ultrasound (DUS) (peak systolic velocity ratio or PSVR ≤ 2.4 and ≤ 3.4). Failure of primary patency is defined as a restenosis > 50% measured by DUS (PSVR > 2.4).

*Optional Secondary Endpoints – collected via a 6 Month follow-up visit

At the discrection of the investigator, a 6 month follow-up visit may be scheduled. All safety and effectivenss data that are collected for the 12 month follow-up will be collected at this optional visit.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/08/13
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Candidates for this study must meet ALL of the following inclusion criteria to be eligible for enrollment: 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 moderate lifestyle-limiting claudication to mild 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 in the SFA and/or popliteal artery (by visual estimate) and is amenable to PTA and stenting. 7. The target vessel reference diameter will be (by visual estimate) appropriate for treatment with available stent diameter of 5.0 mm. 8. A total of two stents may be used to cover lesions. Overlapping is allowed. 9. 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

Candidates who meet ANY of the following exclusion criteria at the time of the study procedure are NOT eligible for enrollment in the study: 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 Category1 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. Subjects with a stent previously implanted into the target lesion(s). A target vessel with a previously placed stent is permitted as long as the subject device(s) will not come into contact with the previously placed stent during treatment of the target lesion(s). 16. Lesions requiring the use of more than two stents. 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. Note: One limb may be enrolled in the study, but only if the second limb is planned to be treated after the 30 day follow-up telephone screening has taken place. The limb that may be enrolled has to be the limb with the more severe lesion and the reasons for treating this specific limb will need to be stated in the CRF.

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Addresses

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    • Bard Peripheral Vascular, Inc.
    • 1625 West 3rd Street
    • 85281  Tempe, Arizona
    • United States
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    • Universitäts-Herzzentrum Freiburg Bad Krozingen Klinik für Kardiologie u. Angiologie II
    • Mr.  Prof. Dr. med.  Thomas  Zeller 
    • Südring 15
    • 79189   Bad Krozingen
    • Germany
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    • Universitäts-Herzzentrum Freiburg Bad Krozingen, Klinik für Kardiologie u. Angiologie II
    • Mr.  Dr. med.  Ulrich  Beschorner 
    • 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, Arizona
    • United States
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Status

  •   Recruiting complete, follow-up complete
  •   2015/01/23
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.