Infrapopliteal artery stenotic or occlusive lesions
Conditions
Interventions
Test group:Treatment with the sirolimus eluting resorbable peripheral arterial scaffold system
Control group:Treatment with balloon angioplasty
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Subject must be at 18-85 years, both gender; 2.Subjects who can understand the purpose of the trial, voluntarily sign the informed consent, and are willing to complete the 12-month follow-up as required by the protocol; 3.Patients with severe lower limb ischemia and Rutherford grade 2-5; 4.Popliteal artery target lesion stenosis = 70% or occlusion; 5.The target lesion is located below the popliteal artery bifurcation (including the bifurcation); 6.Only one of the three branches is allowed to be the target vessel; 7.Each target lesion is =48 mm in length, and only one stent is allowed to cover each target lesion, with a vessel diameter of 2.5-4.0 mm; 8.The target lesion is in the anterior tibial artery, posterior tibial artery, more than the proximal 2/3 of the peroneal artery or the tibiofibular trunk; 9.The target vessel has a good distal outflow tract (<50% stenosis); 10.Expected survival greater than 12 months.
Exclusion criteria
Exclusion criteria: 1.Severe liver and kidney dysfunction (creatinine is 2 times higher than the normal value or renal dialysis, alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 5 times the upper limit of normal); 2.The target lesion is located above the popliteal artery bifurcation; 3.The target lesion is located below the ankle joint; 4.The target vessel has a history of surgery; 5.The target vessel has a history of endovascular volume reduction surgery; 6.Target vessel thrombosis or acute thrombosis requiring thrombolysis and thrombectomy; 7.Severe calcification of target lesions (PACSS calcification grade 3 and above); 8.Planning for major amputation prior to surgery; 9.Have systemic coagulation disorder or hypercoagulability; 10.Lower limb artery surgery or thrombolytic therapy within the past 6 weeks; 11.Stroke occurred within 3 months before surgery, or stroke occurred more than 3 months before surgery and was accompanied by severe hemiplegia and aphasia sequelae; 12.Acute myocardial infarction or angina pectoris within 30 days before surgery; 13.Target vessel in-stent restenosis; 14.The guidewire cannot pass through the target lesion; 15.Patients who had received drug-eluting balloon therapy within 6 months before surgery; 16.Patients whose inflow tract (including the ipsilateral iliac artery, femoral artery, and popliteal artery) lumen still has >30% stenosis before or after treatment; 17.Before treatment, the inflow tract, including the ipsilateral iliac artery, femoral artery, and popliteal artery, had stenosis or occlusion of more than 150 mm in length; 18.Lower extremity artery aneurysms; 19.hromboangiitis obliterans (Buerger disease); 20.The inframalar artery had no unobstructed vessels before endovascular treatment (>50% stenosis or occlusion); 21.Subjects with known allergies to aspirin, heparin, clopidogrel, contrast agents, poly (L-lactic acid) (PLLA), racemic poly (lactic acid) (PDLLA), rapamycin, platinum and aliphatic polyester copolymers or blends, and those who cannot tolerate postoperative dual-antibody therapy; 22.Patients who have participated in other clinical trials during the same period and have not been discharged; 23.Pregnant or planning to become pregnant during this trial; 24.Patients whose target lesions require volume reduction during angiography, such as thromboendarterectomy, percutaneous transluminal atherectomy, or laser treatment; 25.The researcher believes that the subject is not suitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| target lesion primary patency rate at 12 month; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate;Surgical success rate;Improvement in Rutherford Rating (Clinical Success);Ankle Brachial Index(ABI);Target lesion restenosis rate;Initial patency rate of target lesions at 3 and 6 months;Mortality rate;Clinically Driven Revascularization Rate;Incidence of major amputations above the ankle on the target lesion side;Late lumen loss;Ulcer wound healing rate; | — |
Countries
China
Contacts
Public ContactWeiguo Fu
Zhongshan Hospital Fudan University
Outcome results
None listed