Lower extremity arteriosclerosis obliterans
Conditions
Interventions
Bare Metal Stent group:Target lesion implanted in Bare Metal Stent
Stent Graft group:Target lesion implanted in Stent Graft
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Femoral artery TASC II grade D occlusive disease; 2. Rutherford Grade 2–5; 3. Male and non-pregnant female patients aged 18 years or older; 4. Target lesions flow into the blood vessels, but they have been successfully treated before the target lesions are treated; 5. ABI = 0.7 or TBI = 0.5; 6. Life expectancy exceeds 1 year; 7. Angiography; 8. At least one unobstructed distal outflow artery; 9. The lesion can be pre-expanded; 10. Reference vessel diameter between 4.0 mm and 7.5 mm (must be measured instead of estimated).
Exclusion criteria
Exclusion criteria: 1. Patients not suitable for vascular interventional surgery (PTA); 2. Female patients during pregnancy and lactation; 3. Unreachable proximal arterial occlusive disease; 4. Lower extremity aneurysm; 5. Rutherford grade 5 or higher with active infection; 6. Known coagulopathy; 7. Patients known to have an allergic reaction to other anticoagulant/antiplatelet therapy contrast agents for heparin aspirin; 8. Patient life expectancy is less than 1 year; 9. The patient has participated in other drug or device clinical trials and has not completed the expected primary endpoint follow-up of the clinical trials attended; 10. A stroke occurred within 3 months prior to enrollment; 11. Myocardial infarction MI or angina occurred within two weeks of enrollment; 12. Patients with renal failure or chronic kidney disease with serum creatinine =2.5 mg/dl or glomerular filtration rate =30 ml/min per 1.73 m2 within 14 days before surgery or undergoing dialysis; 13. The guidewire cannot pass through the target lesion (successful passage through the target lesion means that the distal end of the guidewire can reach and pass the target lesion in the absence of a restrictive or non-perforated); 14. The patient is unable or unwilling to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ABI;DUS; | — |
Countries
China
Contacts
Public ContactDai Xiangchen
Tianjin Medical University General Hospital
Outcome results
None listed