Study of a Novel Thrombectomy Device to Treat Acute Iliofemoral Deep Venous Thrombosis

Study on the Application of a Novel Aspiration Thrombectomy Device Combined With Catheter-directed Thrombolysis for the Treatment of Acute Iliofemoral Deep Venous Thrombosis

The purpose of this study is to determine whether the novel aspiration thrombectomy device combined with catheter-directed thrombolysis is effective in the treatment of acute iliofemoral deep venous thrombosis (IF-DVT).

Catheter-directed thrombolysis will be performed in eligible patients with acute IF-DVT. A combined mechanical thrombectomy will be used to clear the iliac thrombi in experimental group. The immediate, mid- and long-term outcomes will be recorded. Quantitative data wiil be expressed as mean ± SD, and will be compared with independent-sample t-test or paired-sample t-test. Count data will be expressed as a ratio (or percentage), and the chi-square test or the fisher's exact test will be used for comparisons. A difference with P < 0.05 will be considered statistically significant. All statistical analyses will be performed using IBM SPSS, version 22.0 (SPSS Inc., Chicago, IL, USA).

Inclusion Criteria:

• Clinical diagnosis of iliofemoral deep venous thrombosis
• Symptoms of less than 14 days' duration
• With good function status
• A life expectancy of more than 1 year
• A low risk of bleeding

Exclusion Criteria:

• Without iliac vein thrombosis
• Anticoagulation and/or thrombolysis contraindications
• Systemic infection
• Heart, hepatic, renal function insufficiency