Introducer Curving Technique for Tilt of Transfemoral Günther Tulip Inferior Vena Cava Filter

Introducer Curving Technique for Tilt of Transfemoral Günther Tulip Inferior Vena Cava Filter：A Randomized Double-Blind Comparison

It has been demonstrated that implantation of inferior vena cava filter was safe and effective in the prevention or reduction of fatal pulmonary thromboembolism in numerous clinical researches. When acute deep venous thrombosis need transcatheter thrombolysis, transfemoral Günther Tulip Filter implantation could avoid catheter across the Günther Tulip Filter. Although incidence of significant filter tilting (>10°) is not high (13%-16%), severe tilting of the Günther Tulip Filter may be associated with difficulty or sometimes impossibility of retrieval. It has been reported that a simple technique of keeping tension of the delivery system may prevent significant tilting of the transjugular Günther Tulip Filter in an in-vitro study. But no clinical study of prevention transfemoral Günther Tulip Filter from tilting has been reported. The investigators conducted a randomized, controlled study to test whether the introducer curving technique is useful to decrease the extent of tilting of transfemoral Günther Tulip Filter.

Study Overview

• Status: Completed
• Conditions: Deep Venous Thrombosis
• Intervention / Treatment: Device: curving introducer Günther Tulip Filter; Device: straight introducer Günther Tulip Filter

Detailed Description

The study was designed as a double-blind randomized controlled trial, with research assessors and patients intended to be blind to the intervention status. The staff members performing the assessment were not involved in implementing any aspect of the intervention. 108 patients were randomized to accept curving introducer Günther Tulip Filter and transcatheter thrombolysis or straight introducer Günther Tulip Filter and transcatheter thrombolysis. The assessments include the tilting angle between the axes of inferior vena cava and Günther Tulip Filter after implantation; the tilting angle between the axes of inferior vena cava and Günther Tulip Filter before retrieval; the fluoroscopy time of Günther Tulip Filter retrieval; the rate of retrieval hook adhering vascular wall; the success rate of retrieval.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • ShenYang, Liaoning, China, 110001
      • Department of Radiology, the First Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• acute lower extremity deep vein thrombosis, diagnosed by vascular ultrasound and clinical history

Exclusion Criteria:

• both lower extremities deep vein thrombosis
• Inferior Vena Cava thrombosis
• refractory hypertension (blood pressure > 180/110mmHg)
• contraindication of thrombolysis
• the diameter of Inferior Vena Cava > 35mm or < 14mm
• Inferior Vena Cava venous anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: curving introducer	Device: curving introducer Günther Tulip Filter; The Günther Tulip filter (Vena Cava MReye Filter Set; William Cook Europe, Bjaeverskov, Denmark) The amplitude of introducer curvature was 5°-15° less than the angle between the inferior vena cave axis and the approached iliac vein axis and the distance between the vertex of the curved angle and the hook of the filter was 2-4cm less than the distance between the level of the renal vein confluence and the furcation of inferior vena cave.
Placebo Comparator: straight introducer	Device: straight introducer Günther Tulip Filter; The Günther Tulip filter (Vena Cava MReye Filter Set; William Cook Europe, Bjaeverskov, Denmark)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the tilting angle between the axes of Inferior Vena Cava and Günther Tulip Filter after implantation	just after filter implantation （up to 24 hours）

Secondary Outcome Measures

Outcome Measure	Time Frame
the tilting angle between the axes of Inferior Vena Cava and Günther Tulip Filter before retrieval	just before filter retrieval （up to 90 days）
the fluoroscopy time of Günther Tulip Filter retrieval	just after filter retrieval（up to 90 days）
the rate of retrieval hook adhering vascular wall	just after filter retrieval（up to 90 days）
the success rate of retrieval	just after filter retrieval（up to 90 days）

Collaborators and Investigators

• Sponsor: China Medical University, China
• Investigators: Study Director: Liang Xiao, Ph.D. M.D., First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: April 4, 2011
• First Submitted That Met QC Criteria: April 11, 2011
• First Posted (Estimate): April 12, 2011

Study Record Updates

• Last Update Posted (Estimate): April 26, 2011
• Last Update Submitted That Met QC Criteria: April 25, 2011
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: Filter Tilt; Preventional efficiency; Günther Tulip filter; Transfemoral Approach
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: LXiao-01