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

NCT ID: NCT02414802

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combined thrombectomy device

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

Group Type EXPERIMENTAL

a manual spiral thrombus broken suction device

Intervention Type DEVICE

A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis

catheter-directed thrombolysis

Intervention Type PROCEDURE

catheter-directed thrombolysis will be used in both arms

low-molecular-weight heparin calcium

Intervention Type DRUG

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

urokinase

Intervention Type DRUG

A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy

Catheter-directed thrombolysis

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

Group Type OTHER

catheter-directed thrombolysis

Intervention Type PROCEDURE

catheter-directed thrombolysis will be used in both arms

low-molecular-weight heparin calcium

Intervention Type DRUG

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

urokinase

Intervention Type DRUG

A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy

Interventions

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a manual spiral thrombus broken suction device

A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis

Intervention Type DEVICE

catheter-directed thrombolysis

catheter-directed thrombolysis will be used in both arms

Intervention Type PROCEDURE

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

Intervention Type DRUG

urokinase

A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy

Intervention Type DRUG

Other Intervention Names

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Low-Molecular-Weight Heparin Calcium for Injection Urokinase for Injection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Qianxin Huang

postgraduate student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qingqiao Zhang, PHD

Role: STUDY_DIRECTOR

Xuzhou Medical University

Locations

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Department of Interventional Radiology and Vascular Surgery, the Affiliated Hospital of Xuzhou Medical College

Xuzhou, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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BL2014030

Identifier Type: -

Identifier Source: org_study_id

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