lower extremity arteriosclerosis obliterans, ASO
Conditions
Interventions
Experimental group:Binding peripheral balloon
Control group:Common balloon
Sponsors
Tangdu Hospital,Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: ? Age > 40 years old, gender is not limited; ? The clinical manifestations were intermittent claudication or severe limb ischemia (Rutherford grade 2)Up); ?The main lesion site was superficial femoral artery or popliteal artery, with stenosis =70% and accompanied by symptoms; ? At least one vessel in the distal outflow tract has unobstructed blood flow; ? Target blood vessel diameter 2.5-6.0mm; ? Target lesion length < 180mm; ? Sign informed consent and be able to understand and comply with the requirements of the test protocol.
Exclusion criteria
Exclusion criteria: ?Serum creatinine clearance is less than 30ml/min; ?Blood routine was significantly abnormal, white blood cell count 14.0*10^9/L, platelet count 500*10^9/L; ? Patients with acute thrombosis requiring thrombolysis or thrombolysis; ? subknee femoral artery restenosis in stent; ? Target lesions that cannot be passed through the guide wire; ? Those who are expected to require amputation before intervention; ?Patients with a history of stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within the first three months of enrollment; ?Participants in other clinical trials that may interfere with this trial; ? Pregnant and lactating women; ? Patients with known allergies to the medical devices and drugs involved in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of intraoperative flow-restricted dissection;< 30% diameter narrow;Ultrasound examination by surgeon;Postoperative vascular patency rate;TLR Incidence rate;AE Incidence rate;SAE Incidence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Remedial stent placement rate;ABI; | — |
Countries
China
Contacts
Public ContactZhang Zhang
Tangdu Hospital,Fourth Military Medical University
Outcome results
None listed