Introducer Curving Technique for Tilt of Transfemoral Günther Tulip Inferior Vena Cava Filter
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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 |
- 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 ]
- 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 |
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| China, Liaoning | |
| Department of Radiology, the First Hospital of China Medical University | |
| ShenYang, Liaoning, China, 110001 | |
| 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 Thrombosis Venous Thromboembolism Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Thromboembolism |
ClinicalTrials.gov processed this record on May 19, 2013