Atherosclerosis, Ischemia
Conditions
Keywords
Chocolate balloon, infrapopliteal artery
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.
Interventions
DEVICEchocolate balloon
chocolate balloon dilatation
DEVICEplain balloon
plain balloon dilatation
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-month Primary Patency Rate | 12 months | systolic velocity ratio \>2.4 as measured by Duplex ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate | 1 day | Technical success was defined as residual stenosis less than 30% by final |
| freedom from clinically-driven TLR rate | 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 |
Countries
China
Contacts
Primary Contactyang Li, M.D.
Backup ContactYong quan Gu, M.D.
Outcome results
None listed