Deep Venous ThrombosisNCT01333618
Introducer Curving Technique for Tilt of Transfemoral Günther Tulip Inferior Vena Cava Filter
A study testing curving introducer Günther Tulip Filter and straight introducer Günther Tulip Filter in people with Deep Venous Thrombosis, run by China Medical University, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Deep Venous Thrombosis
- What is being tested?
- curving introducer Günther Tulip Filter and straight introducer Günther Tulip Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute lower extremity deep vein thrombosis, diagnosed by vascular ultrasound and clinical history
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiology, the First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: Introducer Curving Technique for Tilt of Transfemoral Günther Tulip Inferior Vena Cava Filter：A Randomized Double-Blind Comparison
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.
Read the 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.
- Conditions
- Deep Venous Thrombosis
- Being tested
- curving introducer Günther Tulip Filter, straight introducer Günther Tulip Filter
- Keywords
- Filter Tilt, Preventional efficiency, Günther Tulip filter, Transfemoral Approach
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curving introducer Günther Tulip FilterDevice
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 FilterDevice
The Günther Tulip filter (Vena Cava MReye Filter Set; William Cook Europe, Bjaeverskov, Denmark)
| Study group | Role | What they receive |
|---|---|---|
| curving introducer | Experimental | Not described Receives: Device: curving introducer Günther Tulip Filter |
| straight introducer | Placebo comparator | Not described Receives: Device: straight introducer Günther Tulip Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
the tilting angle between the axes of Inferior Vena Cava and Günther Tulip Filter after implantation
Measured: 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
Measured: just before filter retrieval （up to 90 days）
the fluoroscopy time of Günther Tulip Filter retrieval
Measured: just after filter retrieval（up to 90 days）
the rate of retrieval hook adhering vascular wall
Measured: just after filter retrieval（up to 90 days）
the success rate of retrieval
Measured: just after filter retrieval（up to 90 days）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startSep 2008
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Investigators
- Liang Xiao, Ph.D. M.D., Study director, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333618
- Sponsor's protocol ID
- LXiao-01
- Status last verified
- Aug 2008
- First submitted
- 4 Apr 2011
- Last updated
- 26 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducer Curving Technique for Tilt of Transfemoral Günther Tulip Inferior Vena Cava Filter：A Randomized Double-Blind Comparison
- ClinicalTrials.gov ID
- NCT01333618
- Acronym / sponsor ID
- LXiao-01
- Conditions
- Deep Venous Thrombosis
- Keywords
- Filter Tilt, Preventional efficiency, Günther Tulip filter, Transfemoral Approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| curving introducer | Experimental | Device: curving introducer Günther Tulip Filter |
| straight introducer | Placebo comparator | Device: straight introducer Günther Tulip Filter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- acute lower extremity deep vein thrombosis, diagnosed by vascular ultrasound and clinical history
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curving introducer Günther Tulip FilterThe 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. | Device | curving introducer |
| straight introducer Günther Tulip FilterThe Günther Tulip filter (Vena Cava MReye Filter Set; William Cook Europe, Bjaeverskov, Denmark) | Device | straight introducer |
Primary outcome
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）
4 secondary outcomes
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）
the fluoroscopy time of Günther Tulip Filter retrieval
Time frame: just after filter retrieval（up to 90 days）
the rate of retrieval hook adhering vascular wall
Time frame: just after filter retrieval（up to 90 days）
the success rate of retrieval
Time frame: just after filter retrieval（up to 90 days）
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang Xiao, Ph.D. M.D. study director
First Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing curving introducer Günther Tulip Filter and straight introducer Günther Tulip Filter in people with Deep Venous Thrombosis, run by China Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2011.