Skip to main content
OpenTrials
Completed

NCT Number: NCT01333618

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Deep Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Radiology, the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

curving introducer Günther Tulip Filter

Device

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.

straight introducer Günther Tulip Filter

Device

The Günther Tulip filter (Vena Cava MReye Filter Set; William Cook Europe, Bjaeverskov, Denmark)

Primary outcomes

  1. the tilting angle between the axes of Inferior Vena Cava and Günther Tulip Filter after implantation

    Time frame: just after filter implantation （up to 24 hours）

Secondary outcomes

  1. the tilting angle between the axes of Inferior Vena Cava and Günther Tulip Filter before retrieval

    Time frame: just before filter retrieval （up to 90 days）

  2. the fluoroscopy time of Günther Tulip Filter retrieval

    Time frame: just after filter retrieval（up to 90 days）

  3. the rate of retrieval hook adhering vascular wall

    Time frame: just after filter retrieval（up to 90 days）

  4. the success rate of retrieval

    Time frame: just after filter retrieval（up to 90 days）

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 12, 2011
Registry last updated
Apr 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.