Femoropopliteal Artery Stenosis or Occlusion
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. Diagnosed with lower extremity arterial occlusive disease, classified as Rutherford Category 2-5. 3. Subjects who are able to understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to complete the 12-month follow-up as required by the protocol. Imaging Inclusion Criteria: 4. Presence of stenotic or occlusive lesion(s) in the femoropopliteal artery. The target lesion must be located distal to the origin of the superficial femoral artery (SFA) and proximal to or within the P3 segment of the popliteal artery, with a visually assessed stenosis degree of =50%. 5. The target lesion vessel has a lumen diameter between 4 mm and 7 mm, and a single target lesion length is <=150 mm (If the gap between two lesions is <10 mm, they are considered as a single lesion). 6. Patent inflow to the target vessel. Patent inflow is defined as a stenosis degree of <50% in the inflow tract; or a post-treatment residual stenosis of <30%. 7. Good outflow (at least one patent infrapopliteal vessel, confirmed by angiography to have sufficient blood flow to the foot, with a stenosis degree of <50%).
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: 1. History of prior surgical intervention 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 but accompanied by 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 contraindications to anticoagulants, antiplatelet agents, contrast media, sirolimus, polylactic acid (PLA), polycaprolactone (PCL), iron and its degradation products, etc., or those intolerant to post-procedure anticoagulation/antiplatelet therapy. 9. Severe hepatic or renal insufficiency (defined as serum creatinine >2 times the upper limit of normal [ULN] or requiring renal dialysis; or Alanine Aminotransferase [ALT] or Aspartate Aminotransferase [AST] >5 times ULN). 10. Patients considered by the investigator to have severe bleeding or coagulation dysfunction. 11. Subjects currently participating in another clinical trial who 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 50% after pre-dilation of the target lesion. 19. Target lesion located within or adjacent to an aneurysm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Patency Rate of the Target Lesion ; | — |
Countries
China
Contacts
Public ContactWei Guo
First Medical Center of Chinese PLA General Hospital
Outcome results
None listed