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

This study has been completed.
Sponsor:
Information provided by:
China Medical University, China
ClinicalTrials.gov Identifier:
NCT01333618
First received: April 4, 2011
Last updated: April 25, 2011
Last verified: August 2008
  Purpose

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.


Condition Intervention
Deep Venous Thrombosis
Device: curving introducer Günther Tulip Filter
Device: straight introducer Günther Tulip Filter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Introducer Curving Technique for Tilt of Transfemoral Günther Tulip Inferior Vena Cava Filter:A Randomized Double-Blind Comparison

Resource links provided by NLM:


Further study details as provided by China Medical University, China:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • the fluoroscopy time of Günther Tulip Filter retrieval [ Time Frame: just after filter retrieval(up to 90 days) ] [ Designated as safety issue: No ]
  • the rate of retrieval hook adhering vascular wall [ Time Frame: just after filter retrieval(up to 90 days) ] [ Designated as safety issue: No ]
  • the success rate of retrieval [ Time Frame: just after filter retrieval(up to 90 days) ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: September 2008
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333618

Locations
China, Liaoning
Department of Radiology, the First Hospital of China Medical University
ShenYang, Liaoning, China, 110001
Sponsors and Collaborators
China Medical University, China
Investigators
Study Director: Liang Xiao, Ph.D. M.D. China Medical University, China
  More Information

No publications provided

Responsible Party: Liang Xiao Associate professor, Department of Radiology, the First Hospital of China Medical University
ClinicalTrials.gov Identifier: NCT01333618     History of Changes
Other Study ID Numbers: LXiao-01
Study First Received: April 4, 2011
Last Updated: April 25, 2011
Health Authority: China: Ethics Committee

Keywords provided by China Medical University, China:
Filter Tilt
Preventional efficiency
Günther Tulip filter
Transfemoral Approach

Additional relevant MeSH terms:
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Thromboembolism
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014