Atherosclerotic Occlusion
Conditions
Interventions
Investigational group:Subjects selected for the experimental group will undergo implantation using artificial blood vessels produced by Shanghai Changdi Medical Technology Co., Ltd.
Control group:Subjects selected for the control group received implants using artificial blood vessels produced by Gore & Associates, Inc.
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. The subject has been diagnosed with lower limb arteriosclerotic occlusive disease, with severe intermittent claudication not responding well to conservative treatment, requiring treatment through above-knee artery replacement or vascular bypass; 3. The target limb Rutherford classification is grade 3-6; 4. The subject or their legal representative can understand the purpose of the trial, voluntarily sign the informed consent form, has sufficient compliance with the clinical trial protocol, and agrees to complete follow-ups as required by the protocol.
Exclusion criteria
Exclusion criteria: Clinical Exclusion Criteria: 1. Estimated life expectancy of the subject =2.5 mg/dL (221 µmol/L) and not on dialysis; 8. Known allergy to silicone, expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), polypropylene, or inability to tolerate antiplatelet or anticoagulant medications required by the study protocol; 9. Known allergy to contrast agents; 10. Pregnant or breastfeeding women, and women of childbearing potential who cannot or are unwilling to use effective contraception during the study period; 11. Currently participating in another drug or medical device clinical trial; 12. Other medical conditions that, in the investigator’s opinion, may cause non-compliance with the study protocol or confound data interpretation. Angiography Exclusion Criteria: 1. Subjects who previously had an artificial graft or above-knee or below-knee saphenous vein bypass in the target limb; 2. Subjects requiring simultaneous bilateral lower limb interventions; 3. Complete occlusion of all infrapopliteal outflow vessels.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of device-related adverse events;Primary patency rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device Success Rate;Surgery success rate;Primary patency rate;Secondary patency rate;Improvement rate of Rutherford classification ;Resting Ankle-Brachial Index (ABI); | — |
Countries
China
Contacts
Public ContactYuehong Zheng
Peking Union Medical College Hospital
Outcome results
None listed