areriosclerotic obliterans of the lower limbs
Conditions
Interventions
Two groups:VaSecure Paclitaxel drug balloon versus Admiral Xtreme ballon
Sponsors
Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: General inclusion criteria: 1. Aged 18 to 85years; 2. The subjects has obvious symptoms of lower limb ischemia; 3. Rutherford score 2 to 5; 4. Up to 1 target lesion in 1 affected limb can be treated by the device in this study. Patients with 2 affected limbs may be considered for this study, 1 affected limb can be treated separately during the same surgery or subsequent surgery; 5. The subject understand the purpose of the study, is willing to comply with all study requirements of the study and voluntarily to sign the informed consent form. Angiography inclusion criteria: 1. The target lesion is located in superficial femoral artery (SFA)and/or the proximal popliteal artery(PPA) above the knee, That is, the artery segment from the bifurcation of the common femoral artery(CFA)(proximal anatomical landmark)to the distal P1 segment of the popliteal artery(distal anatomical landmark), and it is estimated to have the following characteristics: (1) The target lesion stenosis>=70%; (2) the target lesion length 20 to 300mm, requiring 1 or 2 balloon catheter (the overlap between balloons should be minimized); (3) For diffuse lesion or multiple lesions in the same target vessel, the total length, including the distance between the lesions, should be <=300mm; (4) The length of complete occlusion lesion<=100mm; 2. Patient must at least have one unobstructed inferior knee artery (diameter stenosis<50%); 3. Guidewire can successfully pass the target lesion.
Exclusion criteria
Exclusion criteria: General exclusion criteria: 1. Serious infections have not been controlled and not suitable for surgery; 2. Abnormal blood coagulation function, not suitable for surgery; 3. Patients who cannot receive the recommended antiplatelet and/or anticoagulant therapy; 4. Patients who are known to be allergic to aspirin, clopidogrel, heparin, paclitaxel, angiographic agents, etc.; 5. Subjects undergoing dialysis or immunosuppressive therapy; 6. Acute ischemia and/or acute thrombosis in any artery of lower limbs; 7. Patients who have received local or systemic thrombolysis within 48 hours before surgery; 8. Patients with hemorrhagic stroke or ST-segment elevation myocardial infarction within 3 months; 9. Patients who have taken any operation or interventional treatment within 30 days before the surgery (heart, abdomen or peripheral blood vessels); 10. Patients who will take any surgery or intervention within 30 days after the surgery (heart, abdomen or peripheral blood vessels); 11. The patient has other diseases that may significantly shorten the life expectancy of the patient (<1 year), such as malignant tumors, liver insufficiency, renal insufficiency, cardiac insufficiency, etc.; 12. Target lesions where stents are planned to be implanted (stents are allowed to be used in emergency situations); 13. Before enrollment, it was known that there were target lesions that needed to be treated by another method, such as tumor resection, laser, atherosclerotic plaque resection, cryosurgery, endoluminal instruments, brachytherapy. Do not use embolic devices; 14. The target lesion is restenosis after drug balloon or restenosis after drug stent or restenosis after bypass surgery; 15. Pregnant and breast-feeding women or intention to become pregnant during prior to completion of all follow-up procedures; 16. Pregnant and breast-feeding women (pregnancy test must be taken in 72 hours before the surgery); 17. Any patient participating in another clinical study evaluating a drug or a medical device; 18. Patients currently receiving paclitaxel treatment; 19. Patients considered by the investigator to be unsuitable to participate in study; Angiography exclusion criteria: 1. Guidewire cannot pass the target lesion; 2. Serious calcified lesions where PCI cannot performed; 3. Aneurysm in the target vessel; 4. Lesions in the inflow of iliac artery and cannot be successfully treat in advance; 5. Acute or sub-acute thrombosis is formed in the target vessel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and effect; | — |
Countries
China
Contacts
Public ContactShu Chang
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed