Clinical trial NCT04948502: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Keywords: pulmonary embolism
inferior vena cava filter
deep vein thrombosis
Lead sponsor: ShenZhen KYD Biomedical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-02
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old and life expectancy ≥ 12 months;
2. The diameter of inferior vena cava is between 18.0mm and 26.0mm;
3. 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;
4. 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;
5. Those who can understand the purpose of the trial, cooperate with the follow-up, and sign the informed consent voluntarily.

Exclusion Criteria:

1. Patients with severe stenosis or deformity of the inferior vena cava or severe spinal deformity;
2. Patients with uncontrolled infectious diseases, purulent embolism or fat embolism;
3. Previous vena cava filter implantation history;
4. Thrombosis in the venous access required for the filter implantation;
5. Patients with severe liver and renal dysfunction (ALT\>3 times the upper limit of normal; Creatinine\>225umol/L);
6. Patients with known uncorrectable bleeding or severe coagulation disease;
7. Patients who are allergic to contrast agents, nickel and have contraindication to X-ray;
8. With disease causing difficulties in treatment and evaluation (such as septicemia, bacteremia, toxemia, severe metabolic disease, cancer metastasis, mental illness, etc.);
9. Malignant tumor patients;
10. Pregnant and lactating women, or those who is planning parenthood;
11. Participated in clinical trials of other drugs or medical devices before inclusion and haven't reach the end point time limit;
12. Persons considered by the investigator to be unsuitable for participation in this clinical trial.

Primary outcomes:
measure: Clinical success rate of IVCF implantation
timeFrame: 6 months
Secondary outcomes:
measure: Technical success rate of IVCF implantation
timeFrame: 1 day
measure: Clinical success rate of IVCF retrieval
timeFrame: 90 days
measure: Technical success rate of IVCF retrieval
timeFrame: 90 days
measure: Evaluation of operation performance of filter and transporting system
timeFrame: 90 days
measure: The combined incidence of filter displacement over 20 mm, fracture, tilt (> 15°) and IVC penetration within 6 months after implantation
timeFrame: 6 months
measure: Incidence of pulmonary embolism within 6 months after implantation.
timeFrame: 6 months
measure: The incidence of new or aggravated deep vein thrombosis within 6 months after implantation
timeFrame: 6 months
measure: 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
timeFrame: 30 days, 3 months, and 6 months
measure: The number of days from implantation to retrieval (for patients whose filters have been retrieved)
timeFrame: 90 days
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Guilin
country: China
facility: Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Liuzhou
country: China
facility: Liuzhou Workers' Hospital
state: Guangxi
city: Handan
country: China
facility: Handan First Hospital
state: Hebei
city: Luoyang
country: China
facility: Luoyang Orthopedic-Traumatological Hospital of Henan Province
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Shenyang
country: China
facility: The People's Hospitai of Liaoning Province
state: Liaoning
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Yuncheng
country: China
facility: Yuncheng Central Hospital
state: Shanxi
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Guangqi Chang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: