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

Deep Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333618
• Other study ID #: LXiao-01
• Status: Completed
• Phase: N/A
• First received: April 4, 2011
• Last updated: April 25, 2011
• Start date: September 2008
• Est. completion date: September 2010

Study information

• Verified date: August 2008
• Source: China Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
China	Department of Radiology, the First Hospital of China Medical University	ShenYang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the tilting angle between the axes of Inferior Vena Cava and Günther Tulip Filter after implantation		just after filter implantation (up to 24 hours)	No
Secondary	the tilting angle between the axes of Inferior Vena Cava and Günther Tulip Filter before retrieval		just before filter retrieval (up to 90 days)	No
Secondary	the fluoroscopy time of Günther Tulip Filter retrieval		just after filter retrieval(up to 90 days)	No
Secondary	the rate of retrieval hook adhering vascular wall		just after filter retrieval(up to 90 days)	No
Secondary	the success rate of retrieval		just after filter retrieval(up to 90 days)	No