superficial femoral artery and/or proximal popliteal artery stenosis and occlusion
Conditions
Interventions
Test Group:Peripheral arterial stents
Sponsors
Peking University People's Hospita
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: General Selection Criteria: 1. Age 18-85 years old, gender is not limited, and the researchers assessed life expectancy of more than 1 year; 2. The target lesion is primary stenosis or occlusion of the superficial femoral artery and/or the proximal popliteal artery; 3. The symptoms of peripheral arterial disease are in line with Rutherford's rating of 2 to 5; 4. Those who can understand the purpose of the study, cooperate with clinical follow-up, voluntarily participate in clinical trials, and sign informed consent. Selection criteria for contrast: 5. The target lesion is the superficial femoral artery and/or proximal popliteal artery, ranging from 1 cm below the bifurcation of the common femoral artery to the junction of popliteal arteries P1 and P2; 6. The degree of narrowing of visual target lesions under DSA >= 50%; 7. Intraoperative balloon predistention contrast showing residual narrowing of the lumen diameter of the target lesion=30%, flow-limiting dissection or investigator evaluation requires stent implantation; 8. The length of the target lesion should not exceed 140 mm, and the diameter of the blood vessel should be 3.5-8.0 mm, measured by the contrast scale; (if the limb lesion is damaged, the researcher selects a single target lesion in one of the limbs that meets the protocol criteria); 9. When the use of 1 test stent does not completely cover the target lesion, only 1 additional test stent can be used as a remedy; 10. The degree of stenosis of the influx tract (iliac, femoral artery) of the target lesion before or after the intervention = 50%; 11. At least one natural outflow duct under the knee is unimpeded to the ankle.
Exclusion criteria
Exclusion criteria: General exclusion criteria 1. The target blood vessel has undergone open surgery such as bypass surgery or the target blood vessel has undergone stent restenosis; 2. Screening period serum creatinine > 3mg/dl, or those who are receiving long-term hemodialysis or peritoneal dialysis; 3. Severe coagulation dysfunction; 4. Blood vessel-related major diseases, including: acute lower extremity ischemia, active disseminated intravascular coagulation, thromboangiitis obliterans, deep vein thrombosis, treatment of lateral vascular (deep femoral, superficial femoral or popliteal artery) aneurysm; 5. People with major organ failure or other serious diseases (including severe coronary heart disease, grade 3 or 4 cardiac function, severe neurological or psychiatric history, serious infection; Have received or planned an organ transplant, had a myocardial infarction or had severe gastrointestinal bleeding or hemorrhagic stroke within 3 months prior to enlistment); 6. Those who are known to be allergic to contrast agents, nickel or titanium (nickel-titanium alloys), heparin, aspirin and clopidogrel, and anesthetics; 7. Those who are participating in clinical trials of other medical devices or drugs and have not reached the end point; 8. Women of childbearing age who have a positive pregnancy test during the screening period, or who are pregnant, breastfeeding or are expected to have a birth plan within 1 year; 9. Those who plan on the side of the target lesion or need to have a large amputation; 10. Others who are not suitable for clinical trials are considered by the investigators. Contrast exclusion criteria 11. The guide wire cannot pass through the target lesion; 12. During the operation, the target lesion has received or plans to undergo cryoangiogenic surgery, laser angioplasty, percutaneous intraluminal plaque rotation and other volume reduction surgery; 13. The target lesion before stent implantation is a thrombo-occlusive lesion and is not suitable for stent implantation; 14. The target lesion is severely calcified and cannot complete sufficient pre-dilation; 15. Those who are expected to use or have received drug balloons or drug stents during surgery to treat target blood vessels.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint was the primary patency rate at 12 months for target lesions; | — |
Countries
China
Contacts
Public ContactXiaoming Zhang
Peking University People's Hospita
Outcome results
None listed