Clinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation to Treat Arteriosclerosis Occlusive Disease of Lower Extremity

Atherosclerosis Clinical Trial

Official title:

Clinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation to Treat Arteriosclerosis Occlusive Disease of Lower Extremity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05158283
• Other study ID #: XuanwuH202109
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2022
• Source: Xuanwu Hospital, Beijing
• Contact: yang Li, M.D.
• Phone: 18810432268
• Email: liyang0603[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriosclerosis
• Atherosclerosis
• Ischemia

Intervention

Device:
• chocolate balloon
chocolate balloon dilatation
• plain balloon
plain balloon dilatation

Locations

Country	Name	City	State
China	Gu Yong Quan	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-month Primary Patency Rate	systolic velocity ratio >2.4 as measured by Duplex ultrasound.	12 months
Secondary	Technical success rate	Technical success was defined as residual stenosis less than 30% by final	1 day
Secondary	freedom from clinically-driven TLR rate	it is defined as thefreedom from clinically-driven target lesion revascularization	12 months
Secondary	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 months
Secondary	12-month Limb Salvage Rate	Limb Salvage is defined as the freedom from secondary major amputation	12 months