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

NCT01333618 | Completed DMC

• 1 other identifier: LXiao-01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Venous Thrombosis

Keywords

Filter Tilt; Preventional efficiency; Günther Tulip filter; Transfemoral Approach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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）

Study Arms (2)

curving introducer

EXPERIMENTAL

Device: curving introducer Günther Tulip Filter

straight introducer

PLACEBO COMPARATOR

Device: straight introducer Günther Tulip Filter

Interventions

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.

curving introducer

straight introducer Günther Tulip Filter DEVICE

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

straight introducer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

Department of Radiology, the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Liang Xiao, Ph.D. M.D.

  First Hospital of China Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 12, 2011
• Study Start: September 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 26, 2011

Record last verified: 2008-08

Locations

CN (1)