SaExten IVCF System in Prevention of PE
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of SaExten Vena Cava Filter System (SaExten IVCF 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. Paticipants will undergo inverventions with SaExten IVCF System or Denali IVCF.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The purpose of this study is to evaluate the efficacy and safety of SaExten Vena Cava Filter System (SaExten IVCF 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. Paticipants will undergo inverventions with SaExten IVCF System or Denali IVCF, and be followed-up to 12 months if the implantation is permanent, to evaluate the efficacy and safety of SaExten IVCF System in prevention of PE.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SaExten Vena Cava Filter System Manufacturer: ShenZhen KYD BioTech Co., Ltd. SaExten IVCF system is a retrievable IVCF system consists of two parts: the vena cava filter and the transporting system.The vena cava filter is a mesh filtering device that prevents the formation of pulmonary embolism by filtering the thrombus. SaExten IVCF system can be inserted through jugular or femoral veins, and can be retrieved through femoral veins within 90 days or indwelled permanently. |
Device: SaExten Vena Cava Filter System
Subjects will undergo intervention, be implanted with a SaExten IVCF. IVCF will be retrieved within 90 days or indwelled permanently, depending on the existence of thrombosis and the evaluation of the operator.
Other Names:
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| Active Comparator: Denali inferior vena cava filter Manufacturer: C. R. BARD. Inc, US |
Device: Denali inferior vena cava filter
Subjects will undergo intervention, be implanted with a Denali IVCF. IVCF will be retrieved within 90 days or indwelled permanently, depending on the existence of thrombosis and the evaluation of the operator.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Clinical success rate of IVCF iimplantation [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.
Secondary Outcome Measures
- Technical success rate of IVCF implantation [6 months]
Successful filter implantation is defined as: The filter was successfully implanted with satisfactory shape and position, and no complicationsassociated with the filter occurred during the operation.
- Clinical success rate of IVCF retrieval [90 days]
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 [90 days]
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 [90 days]
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 [6 months]
- Incidence of pulmonary embolism within 6 months after implantation. [6 months]
- The incidence of new or aggravated deep vein thrombosis within 6 months after implantation [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 [30 days, 3 months, and 6 months]
- The number of days from implantation to retrieval(for patients whose filters have been retrieved) [6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years old and life expectancy ≥ 12 months;
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The diameter of inferior vena cava is between 18.0mm and 26.0mm;
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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;
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People at risk of pulmonary embolism (PE) meet at least one of the following conditions:
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Patients with acute DVT who plan to undergo catheter-directed thrombolysis (CDT), percutaneous mechanical thrombectomy (PMT) or surgical thrombectomy;
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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;
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Patients with high risk factors for acute DVT and PE who underwent abdominal, pelvic or lower limb surgery;
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Patients with DVT who have already developed a large area of PE and are at risk of developing PE again;
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DVT accompanied by serious heart and lung disease, pulmonary hypertension;
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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:
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Patients with severe stenosis or deformity of the inferior vena cava or severe spinal deformity;
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Patients with uncontrolled infectious diseases, purulent embolism or fat embolism;
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Previous vena cava filter implantation history;
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Thrombosis in the venous access required for the filter implantation;
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Patients with severe liver and renal dysfunction (ALT>3 times the upper limit of normal; Creatinine>225umol/L);
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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;
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With disease causing difficulties in treatment and evaluation (such as septicemia, bacteremia, toxemia, severe metabolic disease, cancer metastasis, mental illness, etc.);
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Malignant tumor patients;
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Pregnant and lactating women, or those who is planning parenthood;
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Participated in clinical trials of other drugs or medical devices before inclusion and haven't reach the end point time limit;
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Persons considered by the investigator to be unsuitable for participation in this clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | China | 233000 |
| 2 | Beijing Luhe Hospital, Capital Medical University | Beijing | Beijing | China | 100000 |
| 3 | The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | China | 510000 |
| 4 | Shenzhen Second People's Hospital | Shenzhen | Guangdong | China | 518000 |
| 5 | Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | China | 541000 |
| 6 | Liuzhou Workers' Hospital | Liuzhou | Guangxi | China | 545000 |
| 7 | Handan First Hospital | Handan | Hebei | China | 056000 |
| 8 | Luoyang Orthopedic-Traumatological Hospital of Henan Province | Luoyang | Henan | China | 471000 |
| 9 | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China | 450000 |
| 10 | Xiangya Hospital of Central South University | Changsha | Hunan | China | 410000 |
| 11 | Affiliated Hospital of Nantong University | Nantong | Jiangsu | China | 226000 |
| 12 | The People's Hospitai of Liaoning Province | Shenyang | Liaoning | China | 110000 |
| 13 | Yantai Yuhuangding Hospital | Yantai | Shandong | China | 264000 |
| 14 | Shanxi Provincial People's Hospital | Taiyuan | Shanxi | China | 030000 |
| 15 | Yuncheng Central Hospital | Yuncheng | Shanxi | China | 044000 |
| 16 | Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- ShenZhen KYD Biomedical Technology Co., Ltd.
Investigators
- Principal Investigator: Guangqi Chang, Dr., First Affiliated Hospital, Sun Yat-Sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KYD SaExten IVCF