Back to resultsClinical Of Drug-eluting Stent Versus Excimer Laser Ablation Combined Drug-coated Balloon To Treat Arteriosclerosis Occlusive Disease Of Lower Extremity
Primary Purpose
Atherosclerosis, Ischemia
Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drug-eluting Stent
Excimer Laser Ablation Combined Drug-coated Balloon
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring drug-eluting 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 Quan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Intervention: Drug-eluting Stent
Intervention: Excimer Laser Ablation Combined Drug-coated Balloon
Arm Description
Drug-eluting Stent group
Excimer Laser Ablation Combined 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
Technical success was defined as residual stenosis less than 30% by final
freedom from clinically-driven TLR
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,
12-month Limb Salvage Rate
Limb Salvage is defined as the freedom from secondary major amputation
Full Information
NCT ID
NCT05575245
First Posted
August 10, 2022
Last Updated
December 4, 2022
Sponsor
Xuanwu Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT05575245
Brief Title
Clinical Of Drug-eluting Stent Versus Excimer Laser Ablation Combined Drug-coated Balloon To Treat Arteriosclerosis Occlusive Disease Of Lower Extremity
Official Title
Clinical Of Drug-eluting Stent Versus Excimer Laser Ablation Combined Drug-coated Balloon To Treat Arteriosclerosis Occlusive Disease Of Lower Extremity
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The research fund has not yet arrived.
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
October 20, 2024 (Anticipated)
Study Completion Date
October 20, 2024 (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 Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions.
Detailed Description
Prospective randomized controlled study to evaluate the difference of safety，effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the Excimer Laser Ablation Combined Drug-coated Balloon group and drug-eluting stent 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
drug-eluting 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
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Drug-eluting Stent
Arm Type
Active Comparator
Arm Description
Drug-eluting Stent group
Arm Title
Intervention: Excimer Laser Ablation Combined Drug-coated Balloon
Arm Type
Experimental
Arm Description
Excimer Laser Ablation Combined Drug-coated Balloon group
Intervention Type
Device
Intervention Name(s)
Drug-eluting Stent
Intervention Description
Drug-eluting Stent angioplasty
Intervention Type
Device
Intervention Name(s)
Excimer Laser Ablation Combined Drug-coated Balloon
Intervention Description
Excimer Laser Ablation Combined Drug-coated Balloon angioplasty
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
Time Frame
1 day
Title
freedom from clinically-driven TLR
Description
it is defined as the freedom from clinically-driven target lesion revascularization
Time Frame
1 day
Title
Major Adverse Events at 12-month Post Procedure
Description
Major adverse events included death, index limb ischemia, index limb amputation,
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.
Facility Information:
Facility Name
Gu Yong Quan
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
12. IPD Sharing Statement
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Clinical Of Drug-eluting Stent Versus Excimer Laser Ablation Combined Drug-coated Balloon To Treat Arteriosclerosis Occlusive Disease Of Lower Extremity
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