Status:
UNKNOWN
Clinical Study of Stent Versus Direct Atherectomy to Treat Iliac Artery Occlusive Diseases
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Iliac Artery Occlusion
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
This is a randomized study comparing stent and plaque excision systems in treatment of Iliac artery occlusive disease.
Detailed Description
This is a randomized study comparing stent and plaque excision systems in treatment of Iliac artery occlusive disease
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04361071
Start Date
August 1 2018
End Date
December 1 2023
Last Update
April 24 2020
Active Locations (1)
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1
Yongquan Gu
Beijing, Beijing Municipality, China, 100053