Back to resultsClinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
Primary Purpose
Atherosclerosis, Ischemia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
chocolate balloon
plain balloon
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring Chocolate balloon, infrapopliteal artery
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
Experimental
Experimental
Arm Label
Intervention: Chocolate balloon
Intervention: plain balloon
Arm Description
Chocolate balloon group
plain 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 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
NCT05158283
First Posted
December 2, 2021
Last Updated
October 9, 2022
Sponsor
Xuanwu Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT05158283
Brief Title
Clinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
Official Title
Clinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation 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
August 30, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (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 chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions.
Detailed Description
Prospective randomized controlled study to evaluate the difference of safety，effectiveness between chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the chocolate balloon group and plain balloon dilatation group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Ischemia
Keywords
Chocolate balloon, infrapopliteal artery
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: Chocolate balloon
Arm Type
Experimental
Arm Description
Chocolate balloon group
Arm Title
Intervention: plain balloon
Arm Type
Experimental
Arm Description
plain balloon group
Intervention Type
Device
Intervention Name(s)
chocolate balloon
Intervention Description
chocolate balloon dilatation
Intervention Type
Device
Intervention Name(s)
plain balloon
Intervention Description
plain balloon dilatation
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 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
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Clinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
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