Clinical Study of Stent Versus Direct Atherectomy to Treat Iliac Artery Occlusive Diseases

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    120
  • sponsor
    Xuanwu Hospital, Beijing
Updated on 5 March 2022

Summary

This is a randomized study comparing stent and plaque excision systems in treatment of Iliac artery occlusive disease.

Description

This is a randomized study comparing stent and plaque excision systems in treatment of Iliac artery occlusive disease

Details
Condition Iliac Artery Occlusion
Treatment stent, plaque excision system
Clinical Study IdentifierNCT04361071
SponsorXuanwu Hospital, Beijing
Last Modified on5 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The patients have non thrombotic arteriosclerosis obliterans of the common iliac or external iliac arteries
Clinical diagnosis of stenosis or occlusive disease
The patients have unobstructed distal outflow tract
Receiving surgical treatment at the same time

Exclusion Criteria

The patients who have previously implanted stent(s) or stent graft(s) in target leg
Life expectancy less than 12 months
Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure
Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days
Receiving dialysis or immunosuppressant therapy
Recent stroke within past 90 days
Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix) or ticlopidine (Ticlid), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed
Tissue loss due to ischemic disease (Rutherford/Becker category 5 or 6)
Serum creatinine level >/= 2.5 mg/dl at time of screening visit
Known or suspected active infection at the time of the procedure
Bleeding diathesis
Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol
Patients are known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser
Patients are currently participating in any other investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or future participation in such studies prior to the completion of this study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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