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

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

Study Overview

• Status: Recruiting
• Conditions: Iliac Artery Occlusion
• Intervention / Treatment: Device: stent; Device: plaque excision system

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianming Guo, M.D.; Phone Number: 13146369562; Email: guojianming1020@icloud.com
• Study Contact Backup: Name: Yongquan Gu, M.D.; Phone Number: 15901598209; Email: 15901598209@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Yongquan Gu
      • Contact: Yongquan Gu, M.D.; Phone Number: 15901598209; Email: 15901598209@163.com
      • Contact: Jianming Guo, M.D.; Phone Number: 13146369562; Email: guojianming@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stent; Stent group	Device: stent; stent
Active Comparator: Atherectomy; Atherectomy group	Device: plaque excision system; plaque excision system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
12-month Limb Salvage Rate	Limb Salvage is defined as the freedom from secondary major amputation	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Index Limb Ischemia at 6-month Follow up	Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.	6 months
Index Limb Ischemia at 12-month Follow up	Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.	12 months
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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 27, 2017
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: stent; atherectomy; iliac Artery
• Other Study ID Numbers: XuanwuHvas

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes