Clinical Study of Stent Versus Direct Atherectomy to Treat Arteriosclerosis Occlusive Disease of Lower Extremity

Sponsor

Xuanwu Hospital, Beijing (Other)

Overall Status

Completed

CT.gov ID

NCT02840786

Collaborator

Beijing Friendship Hospital (Other), Beijing Chao Yang Hospital (Other)

221

Enrollment

Location

Arms

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized study comparing stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Ischemia	Device: plaque excision system Device: balloon and Stent	N/A

Detailed Description

This is a randomized study comparing balloon angioplasty adjunctive stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)

Study Design

Study Type:

Interventional

Actual Enrollment :

221 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Occlusive Disease of Lower Extremity

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention: Stents Stents group	Device: balloon and Stent
Active Comparator: Intervention: Atherectomy directional atherectomy group	Device: plaque excision system

Arm

Intervention/Treatment

Active Comparator: Intervention: Stents

Stents group

Device: balloon and Stent

Active Comparator: Intervention: Atherectomy

directional atherectomy group

Device: plaque excision system

Outcome Measures

Primary Outcome Measures

12-month Primary Patency Rate [12 months]
systolic velocity ratio >2.4 as measured by Duplex ultrasound.

Secondary Outcome Measures

Technical success [1 day]
Technical success was defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection.
freedom from clinically-driven TLR [12 months]
it is defined as thefreedom from clinically-driven target lesion revascularization
Major Adverse Events at 12-month Post Procedure [12 months]
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-month Limb Salvage Rate [12 months]
Limb Salvage is defined as the freedom from secondary major amputation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Patients were included if they were de novo stenosis>70% or occlusion of the femoropopliteal at least 18 years of age and referred for claudication (Rutherford-Becker class II-III) or critical limb ischemia (Rutherford-Becker class IV-V). They were excluded if they had one or more of the following: 1. Acute or subacute lower limb ischemia; 2. Severe calcification lesions; 3. Total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization 4. untreated ipsilateral iliac artery stenosis>70%, or the distal runoff artery <1 root; 5. Previously lower extremity intervention or surgical graft artery bypass; 6. Severe renal insufficiency, creatinine level greater than 2.5 mg/dL; 7. The patient's platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications; 8. Patients with immune system diseases or malignant tumours; 9. ongoing active infection 10. decompensated congestive heart failure or acute coronary syndrome; 11. Unwillingness to return for future follow-up visits