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

NCT02414802 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-01-18

No results posted yet for this study

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).

Conditions

  • Venous Thrombosis

Interventions

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

Sponsors & Collaborators

  • Xuzhou Medical University

    lead OTHER

Principal Investigators

  • Qingqiao Zhang, PHD · Xuzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02414802 on ClinicalTrials.gov