Superficial femoral artery stenosis or occlusion lesions
Conditions
Interventions
Test group (RCT):Intraoperative use of bioabsorbable peripheral vascular drug-eluting stent system
Control group (RCT):Intraoperative use of drug eluting peripheral balloon dilation catheter
Test group (FIM):Intraoperative use of bioabsorbable peripheral vascular drug-eluting stent system
Sponsors
Beijing Anzhen Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 82 Years
Inclusion criteria
Inclusion criteria: FIM part: 1.Age between 18 and 80 years, any gender. 2.Patients with arteriosclerosis obliterans, the target vessel in the superficial femoral artery. 3.Rutherford classification between 2 and 3. 4.Subject has provided written informed consent prior to participation, understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments. 5.Angiographic stenosis =50% or occlusion. 6.The proximal end of the target lesion does not involve the common femoral artery, and the distal end does not involve the popliteal artery. 7.The length of the target lesion shall not exceed 72mm, and the diameter greater than or equal to 3.8mm and less than or equal to 6.2mm (note: due to limitations in quantitative contrast analysis accuracy, vessel diameter shall be accurate to one decimal place). 8.The target vessel has an adequate inflow tract. Adequate inflow tract is defined as the stenosis rate less than 50%, and if the narrowed or occluded inflow tract is treated before stenting the target lesion, the residual stenosis is < 30%. 9.Angiography demonstrates adequate outflow to the foot distally (at least, one self-foot [dorsalis pedis, posterior tibial, or peroneal] artery is patent). Adequate outflow path is defined as a stenosis of < 50%, and if the stenosed or occluded outflow path is treated before stenting the target lesion, the residual stenosis is < 30%. RCT part: 1.Age between 18 and 82 years, any gender. 2.Patients with arteriosclerosis obliterans, the target vessel in the superficial femoral artery. 3.Rutherford classification between 2 and 4. 4.Subject has provided written informed consent prior to participation, understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments. 5.Angiographic stenosis =50% or occlusion. 6.The proximal end of the target lesion does not involve the common femoral artery, and the distal end does not involve the popliteal artery. 7.The length of the target lesion shall not exceed 72mm, and the diameter greater than or equal to 3.8mm and less than or equal to 6.2mm (note: due to limitations in quantitative contrast analysis accuracy, vessel diameter shall be accurate to one decimal place). 8.The target vessel has an adequate inflow tract. Adequate inflow tract is defined as the stenosis rate less than 50%, and if the narrowed or occluded inflow tract is treated before stenting the target lesion, the residual stenosis is < 30%. 9.Angiography demonstrates adequate outflow to the foot distally (at least, one self-foot [dorsalis pedis, posterior tibial, or peroneal] artery is patent). Adequate outflow path is defined as a stenosis of < 50%, and if the stenosed or occluded outflow path is treated before stenting the target lesion, the residual stenosis is < 30%.
Exclusion criteria
Exclusion criteria: The exclusion criteria for FIMs and RCTs are the same. 1. Patient plans for any other vascular surgical interventions in the ipsilateral limb of the target vessel within 30 days after surgery. 2. Patient had any thrombolytic therapy performed within 30 days before surgery. 3. Patient's target lesion has been treated with drug balloon therapy or stent implantation in the past. 4. Patient has known hypersensitivity to aspirin, clopidogrel, heparin, paclitaxel, contrast agents, polylactic acid, etc. 5. Patient has bleeding tendency, coagulation dysfunction, hypercoagulable constitution or refusal of blood transfusion treatment. 6. Patient suffering from other diseases that may cause difficulties in the test or significantly shorten the life expectancy of patients ( 150 µmol/L or white blood cell count < 3.0 × 10^9 /L; Decompensated heart failure (New York Heart Association Class III or IV), myocardial infarction, or coronary artery bypass grafting within the past 3 months; Hemorrhagic or ischemic stroke within the past 3 months; Acute thrombotic venous inflammation, deep vein thrombosis, or vasculitis in the target vessel ipsilateral limb. 9. Pregnancy and lactating woman 10.Patients participating in another clinical trials with interfere with this trial in the same time 11. In the opinion of the investigator, participation in this clinical trial is not appropriate. 12. Thrombus present in target lesion. 13. Target lesion has aneurysm. 14. Artificial vessels have been placed in ipsilateral limbs of target vessels. 15. Two or more stents must be implanted at the target lesion. 16. Severe diffuse lesions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary patency rate of target lesions at 12 months after surgery (RCT part);The primary patency rate of target lesions at 90 days after surgery (FIM part); | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate (FIM and RCT part);Immediate success rate of surgery (FIM and RCT part);Clinical success rate (FIM and RCT part);Target vessel patency rate without TLR at 180 days after surgery (RCT part);The incidences of TLR and CD-TLR at 30 days after surgery (FIM and RCT part);The incidences of TVR and CD-TVR at 30 days after surgery (FIM and RCT part);The incidences of thrombosis in the target lesion sites at 30 days after surgery (FIM and RCT part);The time of the first CD-TLR within 12 months after the initial surgery (FIM and RCT part);Rutherford category changes (FIM and RCT part);ABI changes (FIM and RCT part);The incidences of small amputations (below the ankle joint) in the treatment of lower limbs (FIM and RCT part);The incidences of major adverse events at 30 days after surgery, including all-cause mortality, CD-TLR, and large amputation of the lower limb on the treatment side (FIM and RCT part);Target vessel patency rate without TLR at 12 months after surgery (FIM and RCT part);The incidences of TLR and CD-TLR at 180 days after surgery (FIM and RCT part);The incidences of TLR and CD-TLR at 12 months after surgery (FIM and RCT part);The incidences of TLR and CD-TLR at 18 months after surgery (FIM and RCT part);The incidences of TLR and CD-TLR at 24 months after surgery (FIM and RCT part);The incidences of TVR and CD-TVR at 180 days after surgery (FIM and RCT part);The incidences of TVR and CD-TVR at 12 months after surgery (FIM and RCT part);The incidences of TVR and CD-TVR at 18 months after surgery (FIM and RCT part);The incidences of TVR and CD-TVR at 24 months after surgery (FIM and RCT part);The incidences of thrombosis in the target lesion sites at 180 days after surgery (FIM and RCT part);The incidences of thrombosis in the target lesion sites at 12 months after surgery (FIM and RCT part);The incidences of thrombosis in the target lesion sites at 18 months after surgery (FIM and RCT part);The incidences of thrombosis in the target les | — |
Countries
China
Contacts
Public ContactChen Zhong
Beijing Anzhen Hospital Affiliated to Capital Medical University
Outcome results
None listed