Clinical Of Drug-eluting Stent Versus Excimer Laser Ablation Combined Drug-coated Balloon To Treat Arteriosclerosis Occlusive Disease Of Lower Extremity

Sponsor

Xuanwu Hospital, Beijing (Other)

Overall Status

Withdrawn

CT.gov ID

NCT05575245

Collaborator

(none)

Enrollment

Location

Arms

31.6

Anticipated Duration (Months)

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 Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Ischemia	Device: Drug-eluting Stent Device: Excimer Laser Ablation Combined Drug-coated Balloon	N/A

Detailed Description

Prospective randomized controlled study to evaluate the difference of safety，effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the Excimer Laser Ablation Combined Drug-coated Balloon group and drug-eluting stent 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

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Of Drug-eluting Stent Versus Excimer Laser Ablation Combined Drug-coated Balloon To Treat Arteriosclerosis Occlusive Disease Of Lower Extremity

Actual Study Start Date :

Mar 3, 2022

Anticipated Primary Completion Date :

Oct 20, 2024

Anticipated Study Completion Date :

Oct 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention: Drug-eluting Stent Drug-eluting Stent group	Device: Drug-eluting Stent Drug-eluting Stent angioplasty
Experimental: Intervention: Excimer Laser Ablation Combined Drug-coated Balloon Excimer Laser Ablation Combined Drug-coated Balloon group	Device: Excimer Laser Ablation Combined Drug-coated Balloon Excimer Laser Ablation Combined Drug-coated Balloon angioplasty

Arm

Intervention/Treatment

Active Comparator: Intervention: Drug-eluting Stent

Drug-eluting Stent group

Device: Drug-eluting Stent

Drug-eluting Stent angioplasty

Experimental: Intervention: Excimer Laser Ablation Combined Drug-coated Balloon

Excimer Laser Ablation Combined Drug-coated Balloon group

Device: Excimer Laser Ablation Combined Drug-coated Balloon

Excimer Laser Ablation Combined Drug-coated Balloon angioplasty

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 [1 day]
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,
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:

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.