Pulmonary EmbolismNCT04948502
SaExten Vena Cava Filter System in Prevention of Pulmonary Embolism
A study testing SaExten vena cava filter system and Denali inferior vena cava filter in people with Pulmonary Embolism, run by ShenZhen KYD Biomedical Technology Co., Ltd. at 16 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of SaExten vena cava filter (VCF) system (ShenZhen KYD BioTech Co., Ltd., China) in prevention of pulmonary embolism (PE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- SaExten vena cava filter system and Denali inferior vena cava filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 16 sitesChina
- Study dates
- 13 Aug 2020to 8 Sep 2022
- 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
- Age ≥18 years old and life expectancy ≥ 12 months;
- The diameter of inferior vena cava is between 18.0mm and 26.0mm;
- Patients with acute (≤14 days of onset) proximal (inferior lumen, iliac, femoral, popliteal vein) deep vein thrombosis (DVT), or at risk of pulmonary embolism (PE) caused by thrombus detoxification, with or without symptoms of pulmonary embolism;
- People at risk of pulmonary embolism (PE) meet at least one of the following conditions:
- Patients with acute DVT who plan to undergo catheter-directed thrombolysis (CDT), percutaneous mechanical thrombectomy (PMT) or surgical thrombectomy;
- Patients who have failed anticoagulant therapy, have recurrent PE and/or DVT, and have contraindications to anticoagulant therapy or are at serious risk of bleeding;
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- Floating thrombus in iliac, femoral vein or inferior vena cava;
- Patients with high risk factors for acute DVT and PE who underwent abdominal, pelvic or lower limb surgery;
- Patients with DVT who have already developed a large area of PE and are at risk of developing PE again;
- DVT accompanied by serious heart and lung disease, pulmonary hypertension;
- Severe injuries (such as hip fracture, etc.), accompanied by vascular endothelial injury, accompanied by blood hypercoagulability and anticoagulant therapy contraindications;
- Those who can understand the purpose of the trial, cooperate with the follow-up, and sign the informed consent voluntarily.
Who cannot join
- Patients with severe stenosis or deformity of the inferior vena cava or severe spinal deformity;
- Patients with uncontrolled infectious diseases, purulent embolism or fat embolism;
- Previous vena cava filter implantation history;
- Thrombosis in the venous access required for the filter implantation;
- Patients with severe liver and renal dysfunction (ALT>3 times the upper limit of normal; Creatinine>225umol/L);
- Patients with known uncorrectable bleeding or severe coagulation disease;
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- Patients who are allergic to contrast agents, nickel and have contraindication to X-ray;
- With disease causing difficulties in treatment and evaluation (such as septicemia, bacteremia, toxemia, severe metabolic disease, cancer metastasis, mental illness, etc.);
- Malignant tumor patients;
- Pregnant and lactating women, or those who is planning parenthood;
- Participated in clinical trials of other drugs or medical devices before inclusion and haven't reach the end point time limit;
- Persons considered by the investigator to be unsuitable for participation in this clinical trial.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233000
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541000
Handan First Hospital
Handan, Hebei, 056000
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Liuzhou Workers' Hospital
Liuzhou, Guangxi, 545000
Luoyang Orthopedic-Traumatological Hospital of Henan Province
Luoyang, Henan, 471000
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226000
The People's Hospitai of Liaoning Province
Shenyang, Liaoning, 110000
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518000
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030000
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Yuncheng Central Hospital
Yuncheng, Shanxi, 044000
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
About this study
Official title: A Multicenter, Randomized, Positive-controlled Clinical Trial to Verify the Efficacy and Safety of the SaExten Vena Cava Filter System in Prevention of Pulmonary Embolism
The purpose of this study is to evaluate the efficacy and safety of SaExten vena cava filter (VCF) system (ShenZhen KYD BioTech Co., Ltd., China) in prevention of pulmonary embolism (PE).
This is a prospective, multicenter, randomized controlled, positive-controlled clinical trial, which will enroll 204 participants in total. Participants will undergo interventions with SaExten VCF System or Denali filter (C. R. BARD, Inc., USA).
Read the detailed description
The purpose of this study is to evaluate the efficacy and safety of SaExten vena cava filter (VCF) system in prevention of pulmonary embolism (PE).
This is a prospective, multicenter, randomized controlled, positive-controlled clinical trial, which will enroll 204 participants in total, with 102 in each group. Participants will undergo interventions with SaExten VCF System or Denali filter, and be followed up to 12 months if the implantation is permanent, to evaluate the efficacy and safety of SaExten VCF System in prevention of PE.
- Conditions
- Pulmonary Embolism
- Being tested
- SaExten vena cava filter system, Denali inferior vena cava filter
- Keywords
- pulmonary embolism, inferior vena cava filter, deep vein thrombosis
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaExten vena cava filter systemDevice
Also called SaExten VCF system
Subjects will undergo intervention, be implanted with a SaExten filter. The filter will be retrieved within 90 days or indwelled permanently, depending on the existence of thrombosis and the evaluation of the physician.
Denali inferior vena cava filterDevice
Also called Denali IVCF
Subjects will undergo intervention, be implanted with a Denali filter. The filter will be retrieved within 90 days or indwelled permanently, depending on the existence of thrombosis and the evaluation of the physician.
| Study group | Role | What they receive |
|---|---|---|
| SaExten vena cava filter | Experimental | Manufacturer: ShenZhen KYD BioTech Co., Ltd., China. SaExten vena cava filter system is a retrievable filter system consisting of two parts: the vena cava filter and the delivering system. The vena cava filter is a mesh filtering device that prevents the formation of pulmonary embolism by filtering the thrombus. The SaExten vena cava filter can be inserted through jugular or femoral veins, and can be retrieved through jugular vein within 90 days or indwelled in vena cava permanently. Receives: Device: SaExten vena cava filter system |
| Denali inferior vena cava filter | Active comparator | Manufacturer: C. R. BARD, Inc., USA Receives: Device: Denali inferior vena cava filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate of IVCF implantation
Clinical success requires the following three factors:
- No clinical symptomatic pulmonary embolism occurred within 6 months after long-term filter implantation, which was confirmed by CT pulmonary angiography (CTPA); No clinical pulmonary embolism occurred between the time of filter implantation and the time of filter retrieval, which was confirmed by pulmonary angiography.
- The IVCF was successfully implanted with satisfactory shape and position;
- No filter fracture, no displacement over 20 mm , no inclination (> 15°) during implantation/retrieval, no IVC penetration, no thrombosis of the IVC, and no implant-related or operation-related deaths.
Measured: 6 months
Secondary outcomes (9)
Technical success rate of IVCF implantation
Successful filter implantation is defined as: The filter was successfully implanted with satisfactory shape and position, and no complications associated with the filter occurred during the operation procedure.
Measured: 1 day
Clinical success rate of IVCF retrieval
Clinical success of filter recovery is defined as: The filter was successfully and completely removed from patients attempting to retrieve the filter within 90 days of filter implantation, without complications requiring clinical intervention.
Measured: 90 days
Technical success rate of IVCF retrieval
Successful filter retrieval is defined as: the filter was successfully and completely removed in patients who attempted to retrieve the filter within 90 days after implantation, and no complications associated with the filter occured during the operation.
Measured: 90 days
Evaluation of operation performance of filter and transporting system
Technical success of the filter and transporting system is defined as: during the operation, the marking and development of the transporting system were good, the filter was transported to the expected position of the vena cava smoothly, the preloaded filter was released completely, and all parts of the transporting system were removed from the body smoothly without falling off or breaking.
Measured: 90 days
The combined incidence of filter displacement over 20 mm, fracture, tilt (> 15°) and IVC penetration within 6 months after implantation
These measures are used to describe the incidences of filter post-implantation.
Measured: 6 months
Incidence of pulmonary embolism within 6 months after implantation.
It is used to describe the incidence of PE post-implantation.
Measured: 6 months
The incidence of new or aggravated deep vein thrombosis within 6 months after implantation
It is used to describe the incidence of DVT post-implantation.
Measured: 6 months
The incidence of compound clinical events of pulmonary embolism, IVC thrombosis, death, and recurrent deep venous thrombosis of lower limbs at 30 days, 3 months, and 6 months after vena cava filter implantation
These measures are used to describe the incidence of PE, IVC thrombosis, death, and and recurrent DVT post-implantation.
Measured: 30 days, 3 months, and 6 months
The number of days from implantation to retrieval (for patients whose filters have been retrieved)
It is used to describe the time from IVC filter implantation to retrieval.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start13 Aug 2020
- Primary completion20 Jan 2022
- Study completion8 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies 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
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- ShenZhen KYD Biomedical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guangqi Chang, Dr., Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948502
- Sponsor's protocol ID
- KYD SaExten Vena Cava Filter
- Status last verified
- Sep 2023
- First submitted
- 23 Jun 2021
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Positive-controlled Clinical Trial to Verify the Efficacy and Safety of the SaExten Vena Cava Filter System in Prevention of Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT04948502
- Acronym / sponsor ID
- KYD SaExten Vena Cava Filter
- Conditions
- Pulmonary Embolism
- Keywords
- pulmonary embolism, inferior vena cava filter, deep vein thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- ShenZhen KYD Biomedical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 2 Jul 2021 (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.
The purpose of this study is to evaluate the efficacy and safety of SaExten vena cava filter (VCF) system (ShenZhen KYD BioTech Co., Ltd., China) in prevention of pulmonary embolism (PE).
This is a prospective, multicenter, randomized controlled, positive-controlled clinical trial, which will enroll 204 participants in total. Participants will undergo interventions with SaExten VCF System or Denali filter (C. R. BARD, Inc., USA).
Detailed description
The purpose of this study is to evaluate the efficacy and safety of SaExten vena cava filter (VCF) system in prevention of pulmonary embolism (PE).
This is a prospective, multicenter, randomized controlled, positive-controlled clinical trial, which will enroll 204 participants in total, with 102 in each group. Participants will undergo interventions with SaExten VCF System or Denali filter, and be followed up to 12 months if the implantation is permanent, to evaluate the efficacy and safety of SaExten VCF System in prevention of PE.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SaExten vena cava filter | Experimental | Device: SaExten vena cava filter systemManufacturer: ShenZhen KYD BioTech Co., Ltd., China. SaExten vena cava filter system is a retrievable filter system consisting of two parts: the vena cava filter and the delivering system. The vena cava filter is a mesh filtering device that prevents the formation of pulmonary embolism by filtering the thrombus. The SaExten vena cava filter can be inserted through jugular or femoral veins, and can be retrieved through jugular vein within 90 days or indwelled in vena cava permanently. |
| Denali inferior vena cava filter | Active comparator | Device: Denali inferior vena cava filterManufacturer: C. R. BARD, Inc., USA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years old and life expectancy ≥ 12 months;
- The diameter of inferior vena cava is between 18.0mm and 26.0mm;
- Patients with acute (≤14 days of onset) proximal (inferior lumen, iliac, femoral, popliteal vein) deep vein thrombosis (DVT), or at risk of pulmonary embolism (PE) caused by thrombus detoxification, with or without symptoms of pulmonary embolism;
- People at risk of pulmonary embolism (PE) meet at least one of the following conditions:
- Those who can understand the purpose of the trial, cooperate with the follow-up, and sign the informed consent voluntarily.
Key exclusion criteria (12 listed)
- Patients with severe stenosis or deformity of the inferior vena cava or severe spinal deformity;
- Patients with uncontrolled infectious diseases, purulent embolism or fat embolism;
- Previous vena cava filter implantation history;
- Thrombosis in the venous access required for the filter implantation;
- Patients with severe liver and renal dysfunction (ALT>3 times the upper limit of normal; Creatinine>225umol/L);
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 |
|---|---|---|
| SaExten vena cava filter systemAlso: SaExten VCF systemSubjects will undergo intervention, be implanted with a SaExten filter. The filter will be retrieved within 90 days or indwelled permanently, depending on the existence of thrombosis and the evaluation of the physician. | Device | SaExten vena cava filter |
| Denali inferior vena cava filterAlso: Denali IVCFSubjects will undergo intervention, be implanted with a Denali filter. The filter will be retrieved within 90 days or indwelled permanently, depending on the existence of thrombosis and the evaluation of the physician. | Device | Denali inferior vena cava filter |
Primary outcome
Clinical success rate of IVCF implantation
Time frame: 6 months
Clinical success requires the following three factors: * No clinical symptomatic pulmonary embolism occurred within 6 months after long-term filter implantation, which was confirmed by CT pulmonary angiography (CTPA); No clinical pulmonary embolism occurred between the time of filter implantation and the time of filter retrieval, which was confirmed by pulmonary angiography. * The IVCF was successfully implanted with satisfactory shape and position; * No filter fracture, no displacement over 20 mm , no inclination (> 15°) during implantation/retrieval, no IVC penetration, no thrombosis of the IVC, and no implant-related or operation-related deaths.
9 secondary outcomes
Technical success rate of IVCF implantation
Time frame: 1 day
Clinical success rate of IVCF retrieval
Time frame: 90 days
Technical success rate of IVCF retrieval
Time frame: 90 days
Evaluation of operation performance of filter and transporting system
Time frame: 90 days
The combined incidence of filter displacement over 20 mm, fracture, tilt (> 15°) and IVC penetration within 6 months after implantation
Time frame: 6 months
Incidence of pulmonary embolism within 6 months after implantation.
Time frame: 6 months
The incidence of new or aggravated deep vein thrombosis within 6 months after implantation
Time frame: 6 months
The incidence of compound clinical events of pulmonary embolism, IVC thrombosis, death, and recurrent deep venous thrombosis of lower limbs at 30 days, 3 months, and 6 months after vena cava filter implantation
Time frame: 30 days, 3 months, and 6 months
The number of days from implantation to retrieval (for patients whose filters have been retrieved)
Time frame: 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 29 Sep 2023.
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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.
Guangqi Chang, Dr. principal investigator
First Affiliated Hospital, Sun Yat-Sen University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SaExten vena cava filter system and Denali inferior vena cava filter in people with Pulmonary Embolism, run by ShenZhen KYD Biomedical Technology Co., Ltd. at 16 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 12 inclusion and 12 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 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
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?
Clinical success rate of IVCF implantation (time frame: 6 months). 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 29 Sep 2023.