Peripheral Arterial Disease
Conditions
Interventions
experimental group:Drug-Coated Balloon combined with atherectomy
controlled group:Drug-Coated Balloon
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. patient will be more than or equal to 18 years of age and younger than 80 years, male or female; 2. diagnosed with femoral-popliteal calcified occlusive disease; 3. ultrasound or CTA confirm that calcification exists at least one plane; 4. possess operation indication; 5. no operation contraindication; 6. participate in clinical trial, accept interference and be followed voluntarily.
Exclusion criteria
Exclusion criteria: 1. allergy to paclitaxel; 2. symptomatic myocardial infarction occured in the past 3 months, or unstable angina occured more than or equal to 3 times in the past one month, or severe heart failure can not be well controled by medicine; 3. suffer from severe respiratory insufficiency 4. suffer from severe renal insufficiency; 5. suffer from severe hepatic disease; 6. suffer from therioma or other severe disease, and expectation of life is less than 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| primary patency rate;rate of target lesion revascularization; | — |
Secondary
| Measure | Time frame |
|---|---|
| intermittent claudication;critical lower-extremity ischemic;amputation rate;all-cause mortality; | — |
Countries
China
Contacts
Public ContactGuo Wei
Chinese PLA General Hospital
Outcome results
None listed