SaExten Vena Cava Filter System in Prevention of Pulmonary Embolism

NCT ID: NCT04948502

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-13
• Study Completion Date: 2022-09-08

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.

Conditions

Pulmonary Embolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SaExten vena cava filter system

Intervention Type: DEVICE

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 filter

Manufacturer: C. R. BARD, Inc., USA

Group Type: ACTIVE_COMPARATOR

Denali inferior vena cava filter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

SaExten VCF system; Denali IVCF

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ShenZhen KYD Biomedical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guangqi Chang, Dr.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Beijing Luhe Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Liuzhou Workers' Hospital

Liuzhou, Guangxi, China

Handan First Hospital

Handan, Hebei, China

Luoyang Orthopedic-Traumatological Hospital of Henan Province

Luoyang, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

The People's Hospitai of Liaoning Province

Shenyang, Liaoning, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Yuncheng Central Hospital

Yuncheng, Shanxi, China

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

KYD SaExten Vena Cava Filter

Identifier Type: -

Identifier Source: org_study_id