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

Iliac Artery Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04361071
• Other study ID #: XuanwuHvas
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2019
• Source: Xuanwu Hospital, Beijing
• Contact: Jianming Guo, M.D.
• Phone: 13146369562
• Email: guojianming1020[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Iliac Artery Occlusion

Intervention

Device:
• stent
stent
• plaque excision system
plaque excision system

Locations

Country	Name	City	State
China	Yongquan Gu	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-month Primary Patency Rate	Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis >50% with a peak systolic velocity ratio >2.4 as measured by Duplex ultrasound.	12 months
Primary	12-month Limb Salvage Rate	Limb Salvage is defined as the freedom from secondary major amputation	12 months
Secondary	Index Limb Ischemia at 6-month Follow up	Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.	6 months
Secondary	Index Limb Ischemia at 12-month Follow up	Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.	12 months
Secondary	Major Adverse Events at 12-month Post Procedure	Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization , and significant embolic events, which were defined as causing end-organ damage.	12 months