Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity

Sponsor

Xuanwu Hospital, Beijing (Other)

Overall Status

Recruiting

CT.gov ID

NCT05158257

Collaborator

(none)

144

Enrollment

Location

Arms

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Ischemia	Device: balloon and Stent Device: endovascular debulking and DCB	N/A

Detailed Description

Prospective randomized controlled study to evaluate the difference of safety，effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the endovascular debulking combined drug-coated balloon group and balloon dilatation combined with stent angioplasty 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity

Actual Study Start Date :

Sep 30, 2021

Anticipated Primary Completion Date :

Oct 10, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention: balloon and Stents plain balloon and Stents group	Device: balloon and Stent balloon dilatation combined stent angioplasty
Experimental: Intervention: debulking and drug coated balloon debulking and drug coated balloon group	Device: endovascular debulking and DCB endovascular debulking combined drug-coated balloon

Arm

Intervention/Treatment

Active Comparator: Intervention: balloon and Stents

plain balloon and Stents group

Device: balloon and Stent

balloon dilatation combined stent angioplasty

Experimental: Intervention: debulking and drug coated balloon

debulking and drug coated balloon group

Device: endovascular debulking and DCB

endovascular debulking combined drug-coated balloon

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 the freedom 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

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Patients were included if they were de novo stenosis>70% or occlusion of the femoropopliteal 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. Total occlusions lesions more significant than 20 cm or total occlusion lesions with a suspicion of subintimal wire recanalization 4. untreated ipsilateral iliac artery stenosis>70%, or the distal runoff artery <1 root; 5. 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