NCT02414802

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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).

Conditions

• Venous Thrombosis

Interventions

Type	Name	Description
DEVICE	a manual spiral thrombus broken suction device	A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis
PROCEDURE	catheter-directed thrombolysis	catheter-directed thrombolysis will be used in both arms
DRUG	low-molecular-weight heparin calcium	anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) in both arms at discharge
DRUG	urokinase	A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-04-13
• Last updated: 2017-01-18

Locations

1 site across 1 country: China