SaExten Vena Cava Filter System in Prevention of Pulmonary Embolism

NCT04948502 | Completed

• 1 other identifier: KYD SaExten Vena Cava Filter
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 16

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).

Conditions

Pulmonary Embolism

Keywords

pulmonary embolism; inferior vena cava filter; deep vein thrombosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Technical success rate of IVCF implantation

  1 day

• Clinical success rate of IVCF retrieval

  90 days

• Technical success rate of IVCF retrieval

  90 days

• Evaluation of operation performance of filter and transporting system

  90 days

• The combined incidence of filter displacement over 20 mm, fracture, tilt (> 15°) and IVC penetration within 6 months after implantation

  6 months

Study Arms (2)

SaExten vena cava filter

EXPERIMENTAL

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

Denali inferior vena cava filter

ACTIVE COMPARATOR

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

Device: Denali inferior vena cava filter

Interventions

SaExten vena cava filter system 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.

Also known as: SaExten VCF system

SaExten vena cava filter

Denali inferior vena cava filter 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.

Also known as: Denali IVCF

Denali inferior vena cava filter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Persons considered by the investigator to be unsuitable for participation in this clinical trial.

Sponsors & Collaborators

• ShenZhen KYD Biomedical Technology Co., Ltd.: lead

Study Sites (16)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233000, China

Location

Beijing Luhe Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518000, China

Location

Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, 541000, China

Location

Liuzhou Workers' Hospital

Liuchow, Guangxi, 545000, China

Location

Handan First Hospital

Handan, Hebei, 056000, China

Location

Luoyang Orthopedic-Traumatological Hospital of Henan Province

Luoyang, Henan, 471000, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

Location

The People's Hospitai of Liaoning Province

Shenyang, Liaoning, 110000, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030000, China

Location

Yuncheng Central Hospital

Yuncheng, Shanxi, 044000, China

Location

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

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Study Officials

• Guangqi Chang, Dr.

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 2, 2021
• Study Start: August 13, 2020
• Primary Completion: January 20, 2022
• Study Completion: September 8, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

CN (16)