| Study name |
Drug‐coated balloon versus drug‐coated balloon with atherectomy for the treatment of femoral‐popliteal calcified occlusive disease: a randomized, controlled and prospective study |
| Methods |
Randomised, parallel controlled trial |
| Participants |
100 participants
Inclusion criteria:
participant aged ≥ 18 years, and younger than 80 years, male or female; diagnosed with femoral‐popliteal calcified occlusive disease; ultrasound or CTA confirm that calcification exists at least one plane; possess operation indication; no operation contraindication; participate in clinical trial, accept interference and be followed voluntarily.
Exclusion criteria:
allergy to paclitaxel; symptomatic myocardial infarction occurred in the past 3 months, or unstable angina occurred 3 times or more in the past one month, or severe heart failure that can not be well controlled by medicine; suffer from severe respiratory insufficiency; suffer from severe renal insufficiency; suffer from severe hepatic disease; suffer from therioma or other severe disease, and expectation of life is less than 6 months.
|
| Interventions |
Arm 1: drug‐coated balloon combined with atherectomy
Arm 2: drug‐coated balloon |
| Outcomes |
Primary:
rate of primary patency rate of TLR
Secondary:
intermittent claudication critical lower‐extremity ischaemia amputation rate all‐cause mortality
|
| Starting date |
28 August 2017 |
| Contact information |
Applicant: Jia Senhao
Study leader: Guo Wei |
| Notes |
|
