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(352) 733-0111

Terumo Osprey Iliac

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

This is a multi-center, single arm, non-randomized, prospective clinical study using the Misago® RX Self-expanding Peripheral Stent for treatment of de novo, restenotic, and/or occlusive lesion(s) of the common and/or external iliac artery.

Details

Full study title Occlusive/Stenotic Peripheral artery Revascularization Study for Common and/or External ILIAC Artery Using the Misago RX Self-expanding Peripheral Stent
Protocol number OCR42998
ClinicalTrials.gov ID NCT02793492
Phase N/A

Eligibility

Inclusion Criteria:

  1. Is ≥ 18 years old and of legal consent.

  2. Is willing to comply with all follow-up evaluations at the specified times.

  3. Subject or subject's legal representative has been informed of and understands the nature of the study and provides signed informed consent to participate in the study.

  4. Has a Rutherford Clinical Category Score of 2, 3 or 4.

  5. Radiographic evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s) in the common iliac artery and/or external iliac artery.

Exclusion Criteria:

  1. Has had previous stent or stent-graft implantation in the target lesion(s).

  2. Has a contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug used during the study according to the protocol.

  3. Has known hypersensitivity to contrast material that cannot be adequately pretreated.

  4. Has known hypersensitivity to nickel-titanium (nitinol).

Lead researcher

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

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