Back to resultsSaExten Vena Cava Filter System in Prevention of Pulmonary Embolism
Primary Purpose
Pulmonary Embolism
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SaExten vena cava filter system
Denali inferior vena cava filter
Sponsored by
About this trial
This is an interventional prevention trial for Pulmonary Embolism focused on measuring pulmonary embolism, inferior vena cava filter, deep vein thrombosis
Eligibility Criteria
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
- The First Affiliated Hospital of Bengbu Medical College
- Beijing Luhe Hospital, Capital Medical University
- The First Affiliated Hospital of Sun Yat-sen University
- Shenzhen Second People's Hospital
- Affiliated Hospital of Guilin Medical University
- Liuzhou Workers' Hospital
- Handan First Hospital
- Luoyang Orthopedic-Traumatological Hospital of Henan Province
- The First Affiliated Hospital of Zhengzhou University
- Xiangya Hospital of Central South University
- Affiliated Hospital of Nantong University
- The People's Hospitai of Liaoning Province
- Yantai Yuhuangding Hospital
- Shanxi Provincial People's Hospital
- Yuncheng Central Hospital
- Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SaExten vena cava filter
Denali inferior vena cava filter
Arm Description
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.
Manufacturer: C. R. BARD, Inc., USA
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Incidence of pulmonary embolism within 6 months after implantation.
It is used to describe the incidence of PE post-implantation.
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.
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.
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.
Full Information
NCT ID
NCT04948502
First Posted
June 23, 2021
Last Updated
September 27, 2023
Sponsor
ShenZhen KYD Biomedical Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04948502
Brief Title
SaExten Vena Cava Filter System in Prevention of Pulmonary Embolism
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
January 20, 2022 (Actual)
Study Completion Date
September 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ShenZhen KYD Biomedical Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
pulmonary embolism, inferior vena cava filter, deep vein thrombosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SaExten vena cava filter
Arm Type
Experimental
Arm Description
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.
Arm Title
Denali inferior vena cava filter
Arm Type
Active Comparator
Arm Description
Manufacturer: C. R. BARD, Inc., USA
Intervention Type
Device
Intervention Name(s)
SaExten vena cava filter system
Other Intervention Name(s)
SaExten VCF system
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Denali inferior vena cava filter
Other Intervention Name(s)
Denali IVCF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical success rate of IVCF implantation
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Technical success rate of IVCF implantation
Description
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.
Time Frame
1 day
Title
Clinical success rate of IVCF retrieval
Description
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.
Time Frame
90 days
Title
Technical success rate of IVCF retrieval
Description
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.
Time Frame
90 days
Title
Evaluation of operation performance of filter and transporting system
Description
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.
Time Frame
90 days
Title
The combined incidence of filter displacement over 20 mm, fracture, tilt (> 15°) and IVC penetration within 6 months after implantation
Description
These measures are used to describe the incidences of filter post-implantation.
Time Frame
6 months
Title
Incidence of pulmonary embolism within 6 months after implantation.
Description
It is used to describe the incidence of PE post-implantation.
Time Frame
6 months
Title
The incidence of new or aggravated deep vein thrombosis within 6 months after implantation
Description
It is used to describe the incidence of DVT post-implantation.
Time Frame
6 months
Title
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
Description
These measures are used to describe the incidence of PE, IVC thrombosis, death, and and recurrent DVT post-implantation.
Time Frame
30 days, 3 months, and 6 months
Title
The number of days from implantation to retrieval (for patients whose filters have been retrieved)
Description
It is used to describe the time from IVC filter implantation to retrieval.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
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.
Exclusion Criteria:
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;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guangqi Chang, Dr.
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233000
Country
China
Facility Name
Beijing Luhe Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Facility Name
Affiliated Hospital of Guilin Medical University
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541000
Country
China
Facility Name
Liuzhou Workers' Hospital
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545000
Country
China
Facility Name
Handan First Hospital
City
Handan
State/Province
Hebei
ZIP/Postal Code
056000
Country
China
Facility Name
Luoyang Orthopedic-Traumatological Hospital of Henan Province
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471000
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Facility Name
The People's Hospitai of Liaoning Province
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Facility Name
Shanxi Provincial People's Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Name
Yuncheng Central Hospital
City
Yuncheng
State/Province
Shanxi
ZIP/Postal Code
044000
Country
China
Facility Name
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
12. IPD Sharing Statement
Learn more about this trial
SaExten Vena Cava Filter System in Prevention of Pulmonary Embolism
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