lower extremity arteriosclerosis obliterans
Conditions
Interventions
Experimental group:Constrained peripheral balloon dilation catheter treatment
Control group:Peripheral balloon dilation catheter treatment
Sponsors
First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) ASO patients diagnosed by CCD or CTA; 2) Age 18-80 years old; 3) Meet the indications for endovascular treatment; 4) lower extremity vascular disease; 5) Intermittent claudication or ischemic resting pain (Rutherford scale 2-4); 6) Significant (=70%) superficial femoral artery or popliteal artery stenosis (the length of the lesion stenosis is 20~180mm), manifested as intravascular revascularization; 7) At least one blood vessel in the distal outflow tract has unobstructed blood flow; 8) Complete case data.
Exclusion criteria
Exclusion criteria: 1) Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval =470 ms); According to NYHA criteria, patients with grade ? to ? cardiac insufficiency or left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 ULN), have a tendency to bleed or are receiving thrombolytic or anticoagulant therapy; 3) Leukocyte 2.5mg/dL; AST and/or ALT > 2 times the normal upper limit); 5) Congenital lower limb dysfunction or vascular disease; 6) Life expectancy < 12 months; 7) The investigator judges that it is not suitable to participate in the clinical trial; 8) Angiographic exclusion criteria include: A previous bypass graft or stent at the target vessel; The therapeutic balloon cannot pass through the iliac stent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of intraoperative flow-restricted dissection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Remedial stent implantation rate;Ankle-brachial index;The rate of freedom from target lesion revascularization; | — |
Countries
China
Contacts
Public ContactYan Song
First Affiliated Hospital of Zhengzhou University
Outcome results
None listed