NCT02414802

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 13, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

March 25, 2015

Last Update Submit

January 15, 2017

Conditions

Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

  • patency of lower extremity deep venous

    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

    up to 36 months

Secondary Outcomes (5)

  • technical success rate

    intraoperation

  • thrombus removal rate

    intraoperation

  • complications

    intraoperation

  • blood loss

    intraoperation

  • improvement of clinical symptoms and signs

    up to 36 months

Other Outcomes (1)

  • incidence of postthrombotic syndrome

    up to 36 months

Study Arms (2)

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

Device: a manual spiral thrombus broken suction deviceProcedure: catheter-directed thrombolysisDrug: low-molecular-weight heparin calciumDrug: urokinase

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

Procedure: catheter-directed thrombolysisDrug: low-molecular-weight heparin calciumDrug: urokinase

Interventions

a manual spiral thrombus broken suction deviceDEVICE

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

Combined thrombectomy device
catheter-directed thrombolysisPROCEDURE

catheter-directed thrombolysis will be used in both arms

Catheter-directed thrombolysisCombined thrombectomy device
low-molecular-weight heparin calciumDRUG

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

Also known as: Low-Molecular-Weight Heparin Calcium for Injection
Catheter-directed thrombolysisCombined thrombectomy device
urokinaseDRUG

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

Also known as: Urokinase for Injection
Catheter-directed thrombolysisCombined thrombectomy device

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Without iliac vein thrombosis
  • Anticoagulation and/or thrombolysis contraindications
  • Systemic infection
  • Heart, hepatic, renal function insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Xuzhou, Jiangsu, 221006, China

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

InjectionsUrokinase-Type Plasminogen Activator

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Qingqiao Zhang, PHD

    Xuzhou Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
postgraduate student

Study Record Dates

First Submitted

March 25, 2015

First Posted

April 13, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 18, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)