Back to resultsClinical Study of Stent Versus Direct Atherectomy to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
Primary Purpose
Atherosclerosis, Ischemia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
plaque excision system
balloon and Stent
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring stents, atherectomy, femoral artery, popliteal artery
Eligibility Criteria
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
Sites / Locations
- Gu Yong Quan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intervention: Stents
Intervention: Atherectomy
Arm Description
Stents group
directional atherectomy group
Outcomes
Primary Outcome Measures
12-month Primary Patency Rate
systolic velocity ratio >2.4 as measured by Duplex ultrasound.
Secondary Outcome Measures
Technical success
Technical success was defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection.
freedom from clinically-driven TLR
it is defined as thefreedom from clinically-driven target lesion revascularization
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-month Limb Salvage Rate
Limb Salvage is defined as the freedom from secondary major amputation
Full Information
NCT ID
NCT02840786
First Posted
July 19, 2016
Last Updated
December 2, 2019
Sponsor
Xuanwu Hospital, Beijing
Collaborators
Beijing Friendship Hospital, Beijing Chao Yang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02840786
Brief Title
Clinical Study of Stent Versus Direct Atherectomy to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
Official Title
Occlusive Disease of Lower Extremity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
Collaborators
Beijing Friendship Hospital, Beijing Chao Yang Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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)
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Ischemia
Keywords
stents, atherectomy, femoral artery, popliteal artery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Stents
Arm Type
Active Comparator
Arm Description
Stents group
Arm Title
Intervention: Atherectomy
Arm Type
Active Comparator
Arm Description
directional atherectomy group
Intervention Type
Device
Intervention Name(s)
plaque excision system
Intervention Type
Device
Intervention Name(s)
balloon and Stent
Primary Outcome Measure Information:
Title
12-month Primary Patency Rate
Description
systolic velocity ratio >2.4 as measured by Duplex ultrasound.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Technical success
Description
Technical success was defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection.
Time Frame
1 day
Title
freedom from clinically-driven TLR
Description
it is defined as thefreedom from clinically-driven target lesion revascularization
Time Frame
12 months
Title
Major Adverse Events at 12-month Post Procedure
Description
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.
Time Frame
12 months
Title
12-month Limb Salvage Rate
Description
Limb Salvage is defined as the freedom from secondary major amputation
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Gu Yong Quan
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Study of Stent Versus Direct Atherectomy to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
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