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

Venous Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02414802
• Other study ID #: BL2014030
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 25, 2015
• Last updated: January 15, 2017
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Xuzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
China	Department of Interventional Radiology and Vascular Surgery, the Affiliated Hospital of Xuzhou Medical College	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	technical success rate	The ratio of successful and total number of participants	intraoperation
Secondary	thrombus removal rate	The ratio of preoperative and postoperative thrombosis amount	intraoperation
Secondary	complications	a composite outcome measure of observation of whether there is evidences of puncture site hematoma, vascular injury or vascular rupture	intraoperation
Secondary	blood loss	The volume of blood loss during operation will be recorded	intraoperation
Secondary	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