Back to resultsClinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
Primary Purpose
Atherosclerosis, Ischemia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
balloon and Stent
endovascular debulking and DCB
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring stent, debulking, femoral artery, drug-coated balloon
Eligibility Criteria
Inclusion criteria： 1.all patients signed an informed consent form; 2.digital subtraction angiography (DSA) revealed femoropopliteal artery stenosis above 70% or occlusion resulting in claudication (Rutherford clinical category-Becker class II-III2-3) or critical limb ischemia (CLI) (Rutherford clinical category 4-5-Becker class IV-V) 3.with unobstructed vascular inflow; 4.with at least a vessel runoff; 5. good compliance and regular follow-up.
Exclusion criteria: 1. Acute or subacute lower limb ischemia caused by acute intraluminal thrombus within the target lesion.; 2. Severe calcified lesions （grade 4 in the PACSS scale）; 3. In-stent restenosis lesion or surgical arterial bypass grafting; 4. Severe renal insufficiency: creatinine level greater than 2.5 mg/dL; 5. Platelet count below 100,000/μL or with antiplatelet / anticoagulation contraindications; 6. Immunologic diseases or malignant diseases; 7. Ongoing active infection; 8. Decompensated congestive heart failure or acute coronary syndrome; 9. Refuse to sign the informed consent Unwillingness to comply with follow-up suggestions.
Sites / Locations
- Gu Yong QuanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Intervention: balloon and Stents
Intervention: debulking and drug coated balloon
Arm Description
plain balloon and Stents group
debulking and drug coated balloon 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 rate
Technical success was defined as residual stenosis less than 30% by final
freedom from clinically-driven TLR rate
it is defined as the freedom 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
NCT05158257
First Posted
October 7, 2021
Last Updated
October 9, 2022
Sponsor
Xuanwu Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT05158257
Brief Title
Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
Official Title
Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions.
Detailed Description
Prospective randomized controlled study to evaluate the difference of safety，effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the endovascular debulking combined drug-coated balloon group and balloon dilatation combined with stent angioplasty group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments. At the same time, the peri-operative related factors that may affect the end point events, such as preoperative baseline data, lesion characteristics, imaging features, stent fracture, and end point observation indexes were analyzed by regression analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Ischemia
Keywords
stent, debulking, femoral artery, drug-coated balloon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention: balloon and Stents
Arm Type
Active Comparator
Arm Description
plain balloon and Stents group
Arm Title
Intervention: debulking and drug coated balloon
Arm Type
Experimental
Arm Description
debulking and drug coated balloon group
Intervention Type
Device
Intervention Name(s)
balloon and Stent
Intervention Description
balloon dilatation combined stent angioplasty
Intervention Type
Device
Intervention Name(s)
endovascular debulking and DCB
Intervention Description
endovascular debulking combined drug-coated balloon
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 rate
Description
Technical success was defined as residual stenosis less than 30% by final
Time Frame
1 day
Title
freedom from clinically-driven TLR rate
Description
it is defined as the freedom 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
Inclusion criteria： 1.all patients signed an informed consent form; 2.digital subtraction angiography (DSA) revealed femoropopliteal artery stenosis above 70% or occlusion resulting in claudication (Rutherford clinical category-Becker class II-III2-3) or critical limb ischemia (CLI) (Rutherford clinical category 4-5-Becker class IV-V) 3.with unobstructed vascular inflow; 4.with at least a vessel runoff; 5. good compliance and regular follow-up.
Exclusion criteria: 1. Acute or subacute lower limb ischemia caused by acute intraluminal thrombus within the target lesion.; 2. Severe calcified lesions （grade 4 in the PACSS scale）; 3. In-stent restenosis lesion or surgical arterial bypass grafting; 4. Severe renal insufficiency: creatinine level greater than 2.5 mg/dL; 5. Platelet count below 100,000/μL or with antiplatelet / anticoagulation contraindications; 6. Immunologic diseases or malignant diseases; 7. Ongoing active infection; 8. Decompensated congestive heart failure or acute coronary syndrome; 9. Refuse to sign the informed consent Unwillingness to comply with follow-up suggestions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yang Li, M.D.
Phone
18810432268
Email
liyang0603@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yong quan Gu, M.D.
Phone
15901598209
Email
15901598209@163.com
Facility Information:
Facility Name
Gu Yong Quan
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian ming Guo, M.D.
Phone
13146369562
Email
guojianming@aliyun.com
First Name & Middle Initial & Last Name & Degree
Yong quan Gu, M.D.
Phone
15901598209
Email
15901598209@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
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