Clinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention: Chocolate balloon Chocolate balloon group |
Device: chocolate balloon
chocolate balloon dilatation
|
| Experimental: Intervention: plain balloon plain balloon group |
Device: plain balloon
plain balloon dilatation
|
Outcome Measures
Primary Outcome Measures
- 12-month Primary Patency Rate [12 months]
systolic velocity ratio >2.4 as measured by Duplex ultrasound.
Secondary Outcome Measures
- Technical success [1 day]
Technical success was defined as residual stenosis less than 30% by final
- freedom from clinically-driven TLR [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
Eligibility Criteria
Criteria
Patients were included if they were de novo stenosis>70% or occlusion of the infrapopliteal 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. untreated ipsilateral iliac and femoral-popliteal artery stenosis>70%；4. 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gu Yong Quan | Beijing | Beijing | China | 100053 |
Sponsors and Collaborators
- Xuanwu Hospital, Beijing
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XuanwuH202109