SaExten Vena Cava Filter System in Prevention of Pulmonary Embolism

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).

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: SaExten vena cava filter system; Device: Denali inferior vena cava filter

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 Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233000
      • The First Affiliated Hospital of Bengbu Medical College
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Luhe Hospital, Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • The First Affiliated Hospital of Sun Yat-Sen University
    • Shenzhen, Guangdong, China, 518000
      • Shenzhen Second People's Hospital
  • Guangxi
    • Guilin, Guangxi, China, 541000
      • Affiliated Hospital of Guilin Medical University
    • Liuzhou, Guangxi, China, 545000
      • Liuzhou Workers' Hospital
  • Hebei
    • Handan, Hebei, China, 056000
      • Handan First Hospital
  • Henan
    • Luoyang, Henan, China, 471000
      • Luoyang Orthopedic-Traumatological Hospital of Henan Province
    • Zhengzhou, Henan, China, 450000
      • The first affiliated hospital of Zhengzhou university
  • Hunan
    • Changsha, Hunan, China, 410000
      • Xiangya Hospital of Central South University
  • Jiangsu
    • Nantong, Jiangsu, China, 226000
      • Affiliated Hospital of Nantong University
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • The People's Hospitai of Liaoning Province
  • Shandong
    • Yantai, Shandong, China, 264000
      • Yantai Yuhuangding Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Shanxi Provincial People's Hospital
    • Yuncheng, Shanxi, China, 044000
      • Yuncheng Central Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SaExten vena cava filter; 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.	Device: SaExten vena cava filter 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.; Other Names: SaExten VCF system
Active Comparator: Denali inferior vena cava filter; Manufacturer: C. R. BARD, Inc., USA	Device: Denali inferior vena cava filter; 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.; Other Names: Denali IVCF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	90 days
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.	1 day
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.	6 months
Incidence of pulmonary embolism within 6 months after implantation.	It is used to describe the incidence of PE post-implantation.	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.	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.	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.	90 days

Collaborators and Investigators

• Sponsor: ShenZhen KYD Biomedical Technology Co., Ltd.
• Investigators: Principal Investigator: Guangqi Chang, Dr., First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2020
• Primary Completion (Actual): January 20, 2022
• Study Completion (Actual): September 8, 2022

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: deep vein thrombosis; pulmonary embolism; inferior vena cava filter
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: KYD SaExten Vena Cava Filter

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No