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

Capital Medical University

Status: Unknown

Conditions: Iliac Artery Occlusion

Treatments: Device: stent; Device: plaque excision system

Study type: Interventional

Funder types: Other

Identifiers

NCT04361071

XuanwuHvas

Details and patient eligibility

About

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

Full description

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

Enrollment: 120 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. The patients who have previously implanted stent(s) or stent graft(s) in target leg
2. Life expectancy less than 12 months
3. Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure
4. Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days
5. Receiving dialysis or immunosuppressant therapy
6. Recent stroke within past 90 days
7. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed
8. Tissue loss due to ischemic disease (Rutherford/Becker category 5 or 6)
9. Serum creatinine level >/= 2.5 mg/dl at time of screening visit
10. Known or suspected active infection at the time of the procedure
11. Bleeding diathesis
12. 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.
13. Patients are known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser.
14. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Stent

Active Comparator group

Description:

Stent group

Treatment:

Device: stent

Atherectomy

Active Comparator group

Description:

Atherectomy group

Treatment:

Device: plaque excision system