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).
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
192
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.
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.
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
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.
Time frame: 6 months
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.
Time frame: 1 day
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.
Time frame: 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.
Time frame: 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.
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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
...and 6 more locations
Time frame: 90 days
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.
Time frame: 6 months
Incidence of pulmonary embolism within 6 months after implantation.
It is used to describe the incidence of PE post-implantation.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 90 days