Stenosis or Occlusion of the Superficial Femoral Artery
Conditions
Interventions
Sponsors
First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: 1. Aged 18 to 80 years, male or female. 2. Diagnosis of lower extremity arteriosclerosis obliterans, classified as Rutherford Category 2-5. 3. Subjects who are able to understand the purpose of the trial, voluntarily participate and provide signed informed consent, and are willing to complete the 12-month follow-up as required by the protocol. Imaging Inclusion Criteria: 4. The proximal portion of the target lesion does not involve the common femoral artery, and the distal portion does not involve the popliteal artery. 5. The target lesion is a de novo lesion, presenting as an occlusion or =50% stenosis. 6. The vessel lumen diameter at the target lesion site is between 4 mm and 7 mm, and the length of a single occlusive lesion is =150 mm. 7. The target vessel has patent inflow. Patent inflow is defined as a stenosis of <50%; or a residual stenosis of <30% after treatment. 8. Good outflow is present (at least one patent infrapopliteal vessel, with angiography demonstrating adequate blood flow to the foot, and a stenosis of <50%; or a residual stenosis of <30% after treatment).
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: 1. History of prior surgical procedure on the target vessel. 2. Patients who have undergone arterial surgery or thrombolytic therapy on the target limb within the past 6 weeks. 3. Subjects with a known history of iron overload or iron metabolism disorders, such as hereditary hemochromatosis. 4. Patients who have undergone coronary intervention within 30 days prior to the procedure or for whom it is planned within 30 days after the procedure (including intervention performed during the index procedure). 5. Patients with acute myocardial infarction or unstable angina pectoris within 30 days prior to the procedure. 6. Patients with a stroke within 3 months prior to the procedure; or patients with a stroke occurring more than 3 months prior to the procedure who have severe sequelae such as hemiplegia or aphasia. 7. Patients requiring long-term anticoagulation therapy for conditions unrelated to the study. 8. Subjects with known allergies or intolerances to anticoagulants, antiplatelet agents, contrast media, sirolimus, polylactic acid, zinc, iron, and their degradation products, as well as those unable to tolerate dual antiplatelet therapy post-procedure. 9. Severe hepatic or renal insufficiency (serum creatinine >2 times the upper limit of normal or on renal dialysis; Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >5 times the upper limit of normal). 10. Patients with severe bleeding or coagulation dysfunction, as determined by the investigator. 11. Subjects who are concurrently participating in another clinical trial and have not completed the follow-up period. 12. Pregnant women, or women planning to become pregnant during the study period. 13. Patients with a life expectancy of =1 year. 14. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for clinical trial participation. Imaging Exclusion Criteria: 15. Presence of thrombus in the target vessel, or acute thrombosis requiring thrombolysis or thrombectomy. 16. The target lesion is an in-stent restenosis lesion. 17. Angiography shows severe calcification at the target lesion that cannot be adequately dilated with a balloon angioplasty catheter.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary patency rate of target lesions 12 months after the operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of major adverse events;Clinically driven revascularization rate of target lesions;Success rate of equipment;Technical success rate;Surgical success rate;The primary patency rate of target lesions;The change of ABI;The change in Rutherford's classification; | — |
Countries
China
Contacts
Public ContactWei Guo
First Medical Center of Chinese PLA General Hospital
Outcome results
None listed