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Venous ThrombosisNCT02414802

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

A study testing a manual spiral thrombus broken suction device, catheter-directed thrombolysis and low-molecular-weight heparin calcium in people with Venous Thrombosis, run by Xuzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Venous Thrombosis
What is being tested?
a manual spiral thrombus broken suction device, catheter-directed thrombolysis and low-molecular-weight heparin calcium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
Dec 2014to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Xuzhou, Jiangsu, 221006

Other trials in China

About this study

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

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).

Read the 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).

Being tested
a manual spiral thrombus broken suction device, catheter-directed thrombolysis, low-molecular-weight heparin calcium, urokinase
Medical subject headings
Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • a manual spiral thrombus broken suction deviceDevice

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

  • catheter-directed thrombolysisProcedure or surgery

    catheter-directed thrombolysis will be used in both arms

  • low-molecular-weight heparin calciumDrug

    Also called Low-Molecular-Weight Heparin Calcium for Injection

    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

  • urokinaseDrug

    Also called Urokinase for Injection

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

Study groups in NCT02414802
Study groupRoleWhat they receive
Combined thrombectomy deviceExperimentalA 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
Receives: Device: a manual spiral thrombus broken suction device; Procedure: catheter-directed thrombolysis; Drug: low-molecular-weight heparin calcium; Drug: urokinase
Catheter-directed thrombolysisOtherParticipants 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
Receives: Procedure: catheter-directed thrombolysis; Drug: low-molecular-weight heparin calcium; Drug: urokinase

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 36 months

Secondary outcomes (5)

  1. technical success rate

    The ratio of successful and total number of participants

    Measured: intraoperation

  2. thrombus removal rate

    The ratio of preoperative and postoperative thrombosis amount

    Measured: intraoperation

  3. complications

    a composite outcome measure of observation of whether there is evidences of puncture site hematoma, vascular injury or vascular rupture

    Measured: intraoperation

  4. blood loss

    The volume of blood loss during operation will be recorded

    Measured: intraoperation

  5. improvement of clinical symptoms and signs

    participants will be followed for the duration of hospital stay and will be followed for up to 36 months by clinical examinations

    Measured: up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02414802
Sponsor's protocol ID
BL2014030
Status last verified
Jan 2017
First submitted
25 Mar 2015
Last updated
18 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing a manual spiral thrombus broken suction device, catheter-directed thrombolysis and low-molecular-weight heparin calcium in people with Venous Thrombosis, run by Xuzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

patency of lower extremity deep venous (time frame: up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02414802.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.

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