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

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).

Study Overview

• Status: Unknown
• Conditions: Venous Thrombosis
• Intervention / Treatment: Device: a manual spiral thrombus broken suction device; Procedure: catheter-directed thrombolysis; Drug: low-molecular-weight heparin calcium; Drug: urokinase

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221006
      • Department of Interventional Radiology and Vascular Surgery, the Affiliated Hospital of Xuzhou Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Other Names: Low-Molecular-Weight Heparin Calcium for Injection; Drug: urokinase; A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy; Other Names: Urokinase for Injection
Other: 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	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; Other Names: Low-Molecular-Weight Heparin Calcium for Injection; Drug: urokinase; A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy; Other Names: Urokinase for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
technical success rate	The ratio of successful and total number of participants	intraoperation
thrombus removal rate	The ratio of preoperative and postoperative thrombosis amount	intraoperation
complications	a composite outcome measure of observation of whether there is evidences of puncture site hematoma, vascular injury or vascular rupture	intraoperation
blood loss	The volume of blood loss during operation will be recorded	intraoperation
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	up to 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of postthrombotic syndrome	participants will be followed for up to 36 months to observe the incidence of postthrombotic syndrome which is associated with leg swelling, pain, ulceration	up to 36 months

Collaborators and Investigators

• Sponsor: Xuzhou Medical University
• Investigators: Study Director: Qingqiao Zhang, PHD, Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 25, 2015
• First Submitted That Met QC Criteria: April 7, 2015
• First Posted (Estimate): April 13, 2015

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 15, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Anticoagulants; Heparin; Calcium; Calcium heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Calcium, Dietary
• Other Study ID Numbers: BL2014030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO