Skip to main content
Clinical Trials/NCT02414802
NCT02414802UnknownNot Applicable

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

Xuzhou Medical University1 site in 1 country40 target enrollmentStarted: December 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
patency of lower extremity deep venous

Study Overview

Brief 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Combined thrombectomy device

Experimental

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

Intervention: a manual spiral thrombus broken suction device (Device)

Combined thrombectomy device

Experimental

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

Intervention: catheter-directed thrombolysis (Procedure)

Combined thrombectomy device

Experimental

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

Intervention: low-molecular-weight heparin calcium (Drug)

Combined thrombectomy device

Experimental

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

Intervention: urokinase (Drug)

Catheter-directed thrombolysis

Other

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

Intervention: catheter-directed thrombolysis (Procedure)

Catheter-directed thrombolysis

Other

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

Intervention: low-molecular-weight heparin calcium (Drug)

Catheter-directed thrombolysis

Other

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

Intervention: urokinase (Drug)

Outcomes

Primary Outcomes

patency of lower extremity deep venous

Time Frame: up to 36 months

participants will be followed for the duration of hospital stay and will be followed for up to 36 months by lower limb vein color Doppler ultrasonography

Secondary Outcomes

  • thrombus removal rate(intraoperation)
  • technical success rate(intraoperation)
  • complications(intraoperation)
  • blood loss(intraoperation)
  • improvement of clinical symptoms and signs(up to 36 months)

Investigators

Sponsor
Xuzhou Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Qianxin Huang

postgraduate student

Xuzhou Medical University

Study Sites (1)

Loading locations...

Similar Trials