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

Primary Purpose

Deep Venous Thrombosis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
curving introducer Günther Tulip Filter
straight introducer Günther Tulip Filter
Sponsored by
China Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deep Venous Thrombosis focused on measuring Filter Tilt, Preventional efficiency, Günther Tulip filter, Transfemoral Approach

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Radiology, the First Hospital of China Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

curving introducer

straight introducer

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 4, 2011
Last Updated
April 25, 2011
Sponsor
China Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT01333618
Brief Title
Introducer Curving Technique for Tilt of Transfemoral Günther Tulip Inferior Vena Cava Filter
Official Title
Introducer Curving Technique for Tilt of Transfemoral Günther Tulip Inferior Vena Cava Filter:A Randomized Double-Blind Comparison
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
China Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Venous Thrombosis
Keywords
Filter Tilt, Preventional efficiency, Günther Tulip filter, Transfemoral Approach

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
curving introducer
Arm Type
Experimental
Arm Title
straight introducer
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
curving introducer Günther Tulip Filter
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
straight introducer Günther Tulip Filter
Intervention Description
The Günther Tulip filter (Vena Cava MReye Filter Set; William Cook Europe, Bjaeverskov, Denmark)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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)
Title
the fluoroscopy time of Günther Tulip Filter retrieval
Time Frame
just after filter retrieval(up to 90 days)
Title
the rate of retrieval hook adhering vascular wall
Time Frame
just after filter retrieval(up to 90 days)
Title
the success rate of retrieval
Time Frame
just after filter retrieval(up to 90 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Xiao, Ph.D. M.D.
Organizational Affiliation
First Hospital of China Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Radiology, the First Hospital of China Medical University
City
ShenYang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China

12. IPD Sharing Statement

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

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