Atherosclerotic lesions of the common iliac artery or external iliac artery
Conditions
Interventions
Investigational group:The subjects who successfully entered the experimental group received stent implantation using the balloon-expandable intravascular covered stent system produced by Jiangsu Biaod
Control group:The subjects selected for the control group underwent stent implantation using the balloon-expandable vascular covered stent produced by Clearstream Technologies Ltd.
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Clinical inclusion criteria: 1. Age >=18 years old; 2. The subject has been diagnosed with lower extremity arteriosclerotic occlusive disease, presenting with intermittent claudication (Rutherford grade 2-3) or ischemic rest pain (Rutherford grade 4), and requires revascularization treatment of the common iliac or external iliac arteries; 3. The subject can understand the purpose of the trial, voluntarily sign the informed consent form, have sufficient compliance with the clinical trial protocol, and agree to complete the follow-up as per the protocol requirements. Angiography inclusion criteria: 1. The subject has angiographic evidence of single or multiple >=50% stenosis (including complete occlusion) of the common iliac artery and/or external iliac artery (including primary and/or restenosis, non-stent implantation) of the target lesion; 2. The target lesion can be successfully passed by a guidewire and pre-expanded with an appropriate-sized PTA balloon (auxiliary devices such as chronic total occlusion (CTO) catheters or recanalization of the true lumen can be used to assist in passing the target lesion); 3. Based on the reference vascular diameter range of 4.5mm - 12.0mm, the total length of the target lesion (unilateral) does not exceed 110mm; 4.The target limb of the subject is confirmed by angiography to have a patent femoral deep artery and/or femoral superficial artery (stenosis < 50%).
Exclusion criteria
Exclusion criteria: Clinical exclusion criteria: 1. The estimated lifespan of the subject is less than 1 year; 2. The subject has experienced a stroke within 3 months prior to the surgery in this trial; 3. The subject has a known uncorrectable bleeding tendency or active coagulation disorder; 4. The subject's serum creatinine is >=2.5 mg/dL (221 umol/L) and has not undergone dialysis; 5. The subject is known to be allergic to stainless steel (i.e., nickel), or cannot tolerate the antiplatelet, anticoagulant or thrombolytic drugs required by the study protocol; 6. The subject has a known allergy to contrast agents; 7. Pregnant or lactating women, or women with potential reproductive capacity but unable or unwilling to use effective contraceptive measures during the study; 8. The subject is currently participating in other clinical trials of drugs or medical devices; 9. The subject has other medical conditions that, according to the investigator's judgment, may prevent compliance with the study protocol or cause data interpretation confusion; Vascular angiography exclusion criteria: 1. The subject has extensive peripheral vascular disease, and the investigator believes that it will impede the safe insertion of the guide sheath; 2. The trial equipment cannot pass through the target lesion; 3. The subject's target lesion has severe calcification, preventing the PTA balloon from fully expanding; 4. Other stent treatments or graft implantations have been performed within a range of = 5mm proximal to the target lesion; 5. The subject has evidence of acute thrombus in the target lesion on angiography; The subject's angiography before receiving the treatment in this study indicates the presence of an iliac artery aneurysm on the target side, or an iliac artery perforation or a vascular dissection that the proposed stent cannot fully cover.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rate of the target lesion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate treatment success rate;Immediate surgical success rate;Immediate technical success rate;TLR rate;TVR rate;Primary patency rate of the target lesion;Secondary patency rate of the target lesion;Improvement rate of Rutherford classification ;ABI; | — |
Countries
China
Contacts
Public ContactYuehong Zheng
Peking Union Medical College Hospital
Outcome results
None listed