Venous ThromboembolismNCT03691753
Safety and Efficacy Study of Fitaya Vena Cava Filter
A study testing Fitaya Vena Cava Filter System and Aegisy Vena Cava Filter in people with Venous Thromboembolism, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 13 sites in China.
Trial summary
A Multi-center, Randomized Controlled Trial to evaluate the safety and efficacy of Fitaya Vena Cava Filter manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for deep vein thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Fitaya Vena Cava Filter System and Aegisy Vena Cava Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 13 sitesChina
- Study dates
- 29 Sep 2018to Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older or equal to 18 years of age, regardless of sex.
- Patients are able to understand the purpose of the trial, voluntarily participated in and signed informed consent, and are willing to complete the follow-up as required by the program.
- Patients diagnosed with inferior deep vein thrombosis (inferior vena cava, Iliac, femoral or popliteal DVT) or pulmonary embolism (PE), and concomitant with one or more of the following situation:
- with the existence of contraindications for anticoagulation therapy.
- complications such as bleeding occurred during anticoagulation therapy.
- pulmonary embolism still recurred after adequate anticoagulation therapy.
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- All reasons cannot achieve sufficient anticoagulant.
- PE coexist with inferior DVT.
- Free thrombosis or large amounts of thrombosis are found in the iliac, femoral, popliteal or inferior vena cava.
- Patients with acute risk factors of DVT and PE needed to undergo abdominal, pelvic or lower limb surgery simultaneously.
- The patients had acute DVT, intend to do Catheter-Directed Thrombolysis (CDT, Percutaneous Mechanical Thrombectomy (PMT), or surgical thrombectomy.
- The investigator determined that the patient had an appropriate femoral or jugular access for implantation of the filter.
- The diameter of inferior vena cava intended to implant the filter is between 18mm and 29mm.
Who cannot join
- Had been implanted with an inferior vena cava filter previously.
- There is thromboembolism in the jugular or femoral vein access of the filter implantation.
- Intended to permanently implant the filter.
- Severe spinal deformity may affect the implantation or removal of filters.
- Renal vein thrombosis, or, inferior vena cava thrombosis spread to renal vein.
- Congenital malformation of inferior vena cava.
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- Having an uncontrolled infectious disease, such as bacteremia or toxaemia.
- Active malignant tumour and tumour metastasis.
- Allergic to imaging agents, materials of filters and conveyor (including nickel and titanium, polyester, Polytetrafluoroethylene (PTFE), nylon polymer materials).
- Patients with X-ray contraindication.
- Liver dysfunction: Alanine transaminase (ALT) or Aspartate transaminase (AST) was 2.5 times higher than the normal upper limit, Serum creatinine (Cr) was two times higher than the normal upper limit.
- Abnormal coagulation function in patients: activated part of thrombin time (APTT)10s more than the normal value.
- Patients with a life expectancy less than 12 months.
- Patients with severe heart and lung dysfunction.
- Pregnant or lactating, or woman planned to be pregnant.
- The patients participated in clinical trials of other drugs or medical devices and did not come out of the group or withdraw within the first 3 months of the screening period of this trial.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Beijing Jishuitan Hospital
Beijing, Beijing Municipality
Jianlong Liu
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Xiaoming Zhang
- Recruiting
The Affiliated Hospital of Shandong University of TCM
Jinan, Shandong
Zhang Dawei
- Recruiting
Frist Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Bin Yang
- Recruiting
Liuzhou Worker's Hospital
Liuzhou, Guangxi
Peiyong Hou
- Recruiting
Ningbo No.2 Hospital
Ningbo, Zhejiang
Dehai Lang
- Recruiting
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Xinwu Lu
- Recruiting
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Honglin Dong
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
Wenjun Zhao
- Recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality
Li Li
- Recruiting
Tianjing Medical University General Hospital
Tianjin, Tianjin Municipality
Xiangchen Dai
- Recruiting
Union Hospital Tongji College Huazhong University of Science and Technology
Wuhan, Hubei
Yiqing Li
- Recruiting
Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou
Rongshu Shi
About this study
Official title: Safety and Efficacy Study of Fitaya Vena Cava Filter for Deep Vein Thrombosis: A Multi-center, Randomized Controlled Trial
A Multi-center, Randomized Controlled Trial to evaluate the safety and efficacy of Fitaya Vena Cava Filter manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for deep vein thrombosis.
Read the detailed description
The trial was mainly for patients with high-risk deep vein thrombosis, and all subjects who passed the screening and signed the informed consent will be enrolled and be randomly divided into the experimental group and the control group according to the proportion of 1:1. For patients who will be allocated to the experimental group will be implanted with Fitaya Vena Cava Filters System, and for patients who will be allocated to the control group will be implanted with Aegisy Vena Cava Filters. Between 0 and 60 days, after the filter was implanted, the investigator will decide whether to withdraw the vena cava filter based on the subject's condition. If successfully withdraw the vena cava filter, the subject will be followed up for 1 month, if the withdraw is unsuccessful, the subject will be followed up for 180 days. This clinical trial is conducted in qualified clinical trial institutions with a planned duration of 16-24 months. Upon completion of the clinical trial report, it will be submitted together with other materials for the application for listing registration in the China Food and Drug Administration (CFDA).
- Conditions
- Venous Thromboembolism
- Being tested
- Fitaya Vena Cava Filter System, Aegisy Vena Cava Filter
- Keywords
- Fitaya, Vena cava filter
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitaya Vena Cava Filter SystemDevice
After the implantation of Fitaya Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath.
Aegisy Vena Cava FilterDevice
After the implantation of Aegisy Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Patients will be treated with Fitaya Vena Cava Filter System. Receives: Device: Fitaya Vena Cava Filter System |
| Control arm | Active comparator | Patients will be treated with Aegisy Vena Cava Filter. Receives: Device: Aegisy Vena Cava Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical success rate of the filter implantation
The clinically successful implantation of vena cava filter should meet the following three requirements simultaneously: 1. The filter was successfully implanted and the shape and positioning were satisfactory. 2. No symptomatic pulmonary embolism occurred in patients with permanent filter implantation within 6 months after implantation and was confirmed by Computed Tomography Pulmonary Angiography (CTPA). No symptomatic pulmonary embolism occurred in patients who had a removal of the filter during its indwelling and was confirmed by CTPA. 3. No rupture, no displacement, no venous penetration, no vena occlusion, no filter implantation or operation-related deaths occurred in the blood vessels.
Measured: 6 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start29 Sep 2018
- Primary completionApr 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoming Zhang, Professor, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691753
- Sponsor's protocol ID
- LT-01
- Status last verified
- Feb 2020
- First submitted
- 28 Sep 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Fitaya Vena Cava Filter for Deep Vein Thrombosis: A Multi-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03691753
- Acronym / sponsor ID
- LT-01
- Conditions
- Venous Thromboembolism
- Keywords
- Fitaya, Vena cava filter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Oct 2018 (actual)
- 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.
A Multi-center, Randomized Controlled Trial to evaluate the safety and efficacy of Fitaya Vena Cava Filter manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for deep vein thrombosis.
Detailed description
The trial was mainly for patients with high-risk deep vein thrombosis, and all subjects who passed the screening and signed the informed consent will be enrolled and be randomly divided into the experimental group and the control group according to the proportion of 1:1. For patients who will be allocated to the experimental group will be implanted with Fitaya Vena Cava Filters System, and for patients who will be allocated to the control group will be implanted with Aegisy Vena Cava Filters. Between 0 and 60 days, after the filter was implanted, the investigator will decide whether to withdraw the vena cava filter based on the subject's condition. If successfully withdraw the vena cava filter, the subject will be followed up for 1 month, if the withdraw is unsuccessful, the subject will be followed up for 180 days. This clinical trial is conducted in qualified clinical trial institutions with a planned duration of 16-24 months. Upon completion of the clinical trial report, it will be submitted together with other materials for the application for listing registration in the China Food and Drug Administration (CFDA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Device: Fitaya Vena Cava Filter SystemPatients will be treated with Fitaya Vena Cava Filter System. |
| Control arm | Active comparator | Device: Aegisy Vena Cava FilterPatients will be treated with Aegisy Vena Cava Filter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Older or equal to 18 years of age, regardless of sex.
- Patients are able to understand the purpose of the trial, voluntarily participated in and signed informed consent, and are willing to complete the follow-up as required by the program.
- Patients diagnosed with inferior deep vein thrombosis (inferior vena cava, Iliac, femoral or popliteal DVT) or pulmonary embolism (PE), and concomitant with one or more of the following situation:
- The investigator determined that the patient had an appropriate femoral or jugular access for implantation of the filter.
- The diameter of inferior vena cava intended to implant the filter is between 18mm and 29mm.
Key exclusion criteria (16 listed)
- Had been implanted with an inferior vena cava filter previously.
- There is thromboembolism in the jugular or femoral vein access of the filter implantation.
- Intended to permanently implant the filter.
- Severe spinal deformity may affect the implantation or removal of filters.
- Renal vein thrombosis, or, inferior vena cava thrombosis spread to renal vein.
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 |
|---|---|---|
| Fitaya Vena Cava Filter SystemAfter the implantation of Fitaya Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath. | Device | Experimental arm |
| Aegisy Vena Cava FilterAfter the implantation of Aegisy Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath. | Device | Control arm |
Primary outcome
The clinical success rate of the filter implantation
Time frame: 6 months after implantation
The clinically successful implantation of vena cava filter should meet the following three requirements simultaneously: 1. The filter was successfully implanted and the shape and positioning were satisfactory. 2. No symptomatic pulmonary embolism occurred in patients with permanent filter implantation within 6 months after implantation and was confirmed by Computed Tomography Pulmonary Angiography (CTPA). No symptomatic pulmonary embolism occurred in patients who had a removal of the filter during its indwelling and was confirmed by CTPA. 3. No rupture, no displacement, no venous penetration, no vena occlusion, no filter implantation or operation-related deaths occurred in the blood vessels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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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.
Xiaoming Zhang, Professor principal investigator
Peking University People's Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitaya Vena Cava Filter System and Aegisy Vena Cava Filter in people with Venous Thromboembolism, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 13 sites 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 13 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Xia (+86 13760184511, xiaying@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical success rate of the filter implantation (time frame: 6 months after implantation). 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 17 Feb 2020.