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

Information source: Xuzhou Medical College
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Venous Thrombosis

Intervention: a manual spiral thrombus broken suction device (Device); catheter-directed thrombolysis (Procedure); low-molecular-weight heparin calcium (Drug); urokinase (Drug)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Xuzhou Medical College

Official(s) and/or principal investigator(s):
Qingqiao Zhang, PHD, Study Director, Affiliation: Xuzhou Medical College

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: patency of lower extremity deep venous

Secondary outcome:

technical success rate

thrombus removal rate

complications

blood loss

improvement of clinical symptoms and signs

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 SPSS, version 16. 0 (SPSS Inc., Chicago, IL, USA).

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

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

Starting date: December 2014
Last updated: April 7, 2015

Page last updated: August 23, 2015

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