Atherosclerosis Clinical Trial
Official title:
Clinical Of Drug-eluting Stent Versus Excimer Laser Ablation Combined Drug-coated Balloon To Treat Arteriosclerosis Occlusive Disease Of Lower Extremity
Verified date | December 2022 |
Source | Xuanwu Hospital, Beijing |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 20, 2024 |
Est. primary completion date | October 20, 2024 |
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. |
Country | Name | City | State |
---|---|---|---|
China | Gu Yong Quan | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing |
China,
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 | Technical success was defined as residual stenosis less than 30% by final | 1 day | |
Secondary | freedom from clinically-driven TLR | it is defined as the freedom from clinically-driven target lesion revascularization | 1 day | |
Secondary | Major Adverse Events at 12-month Post Procedure | Major adverse events included death, index limb ischemia, index limb amputation, | 12 months | |
Secondary | 12-month Limb Salvage Rate | Limb Salvage is defined as the freedom from secondary major amputation | 12 months |
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