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

Xuzhou Medical University

Status: Unknown

Conditions: Venous Thrombosis

Treatments: Drug: urokinase; Procedure: catheter-directed thrombolysis; Drug: low-molecular-weight heparin calcium; Device: a manual spiral thrombus broken suction device

Study type: Interventional

Funder types: Other

Identifiers

NCT02414802

BL2014030

Details and patient eligibility

About

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).

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Combined thrombectomy device

Experimental group

Description:

A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis. Ten million U of urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy. Anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) at discharge

Treatment:

Procedure: catheter-directed thrombolysis

Drug: low-molecular-weight heparin calcium

Device: a manual spiral thrombus broken suction device

Drug: urokinase

Catheter-directed thrombolysis

Other group

Description:

Participants will undergo catheter-directed thrombolysis alone. A total of 100,000 units urokinase will be pulse-spray injected through the catheter once every 4-6 h. Anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) at discharge

Treatment:

Procedure: catheter-directed thrombolysis

Drug: low-molecular-weight heparin calcium

Drug: urokinase