Arteriosclerosis obliterans of the lower extremities
Conditions
Interventions
Trial group:CixPak abdominal muscle balloon for percutaneous transluminal angioplasty (PTA)
Control group:Percutaneous transluminal angioplasty (PTA) is performed using a conventional balloon
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with ASO through imaging examinations and ABI index; 2. Age: 18-85 years old 3. Patients who meet the A-C grade requirements of the "TASC Classification of Main Iliac Artery Lesions (2007)"; 4. Intermittent claudication or ischemic resting pain (Rutherford grade 2-5); 5. Obvious (>=70%) stenosis or occlusion of the lower extremity arteries, and the lesion length is >10cm; 6. At least one blood vessel in the distal outflow tract has unobstructed blood flow. 7. Complete case data; 8. Those who agree to participate in clinical trials and can cooperate to complete them.
Exclusion criteria
Exclusion criteria: 1. Severe heart, lung, liver, kidney and other organ diseases complicated with intolerance to surgery; 2. Congenital lower extremity dysfunction or vasculitic lesions; 3. Incomplete medical records; 4. The researcher determined that the participant was not suitable for this clinical trial. 5. The expected survival time is less than one year; 6. Those with bleeding disorders or other conditions that prevent them from tolerating antiplatelet therapy; 7. The exclusion criteria for angiography include :(1) perforation, dissection (type D or more severe), and severe calcification after pre-dilation; (2) Previously, bypass grafting or stenting was performed at the target blood vessel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of intraoperative flow-restricted dissection;Intraoperative stent placement rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of intraoperative residual stenosis was greater than or equal to 30%;Ankle-brachial index (ABI;Grading of main iliac artery lesions (TASC;12One-month patency rate (color Doppler ultrasound examination);12One month free from the incidence of clinical driven target lesion revascularization (clinically driven target lesionreintervention rate, CD-TLR); | — |
Countries
China
Contacts
Public ContactZhang Jian
The First Affiliated Hospital of China Medical University
Outcome results
None listed