peripheral arterial disease
Conditions
Interventions
experimental group:hyper-slippery PTA balloon catheter specialized for infrapopliteal artery
controlled group :Pacific Xtreme PTA Catheter
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. To be aged 18 years to 80 years, male or female; 2. Patient is willing to meet the require of information recording and follow-up; 3. Patient or patient's legal representative has been informed of the nature of the study, agrees to participate, and has signed an EC approved consent form; 4. Life expectancy longer than 1 year in the investigator's opinion; 5. Patient has documented chronic critical limb ischemia (CLI) in the target limb prior to the study procedure with Rutherford category 4, 5, or 6 without inevitable major amputation; 6. Reference vessel diameter(s) more than 2.0mm; 7. Single or multiple lesions with more than 70% DS of different lengths in one or more main afferent crural vessels including tibioperoneal trunk confirmed by CTA, MRA or DSA and PTA is expected; 8. At least one non-occluded crural vessel with angiographically documented run-off to the foot either directly or through collaterals.
Exclusion criteria
Exclusion criteria: 1. Patient unwilling or unlikely to comply with follow-up schedule; 2. Planned major index limb amputation; 3. Patient participated in another clinical trial which was going on at the time of recruitment; 4. Female at pregnancy or lactation; 5. severe hepatic or renal dysfunction (ALT more than 3 times of normal level, Creatinine more than 225 umol/L); 6. Ruthord 6 with inevitable major amputation; 7. Reference vessel diameter(s) more than 2.0mm, lesion length more than 20cm, severe calcification or at active stage of arteritis; 8. Lesion and/or occlusions located in or extending to the popliteal artery or below the ankle joint space; 9. Inflow lesion or occlusion in the ipsilateral iliac, SFA, or popliteal arteries with length longer than 15 cm; 10. Native or in-stent restenosis, or venous/artificial bypass occlusion; 11. Aneurysm in the target vessel; 12. Acute thrombus in target vesse; 13. Patient is contraindicated for PTA, including the situation of contrast allergy, severe coagulation disorder, end stage renal disease (except hemodialysis), sepsis or severe cardia/pulmonary dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| limb salvage rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of targeted lesion revascularization;primary patency rate;technological success rate; | — |
Countries
China
Contacts
Public ContactShen Chenyang
Outcome results
None listed