Clinical trial NCT03691753: Safety and Efficacy Study of Fitaya Vena Cava Filter
Official title: Safety and Efficacy Study of Fitaya Vena Cava Filter for Deep Vein Thrombosis: A Multi-center, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Thromboembolism
Keywords: Fitaya
Vena cava filter
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-02
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multi-center, Randomized Controlled Trial to evaluate the safety and efficacy of Fitaya Vena Cava Filter manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for deep vein thrombosis.

Detailed description: The trial was mainly for patients with high-risk deep vein thrombosis, and all subjects who passed the screening and signed the informed consent will be enrolled and be randomly divided into the experimental group and the control group according to the proportion of 1:1. For patients who will be allocated to the experimental group will be implanted with Fitaya Vena Cava Filters System, and for patients who will be allocated to the control group will be implanted with Aegisy Vena Cava Filters. Between 0 and 60 days, after the filter was implanted, the investigator will decide whether to withdraw the vena cava filter based on the subject's condition. If successfully withdraw the vena cava filter, the subject will be followed up for 1 month, if the withdraw is unsuccessful, the subject will be followed up for 180 days. This clinical trial is conducted in qualified clinical trial institutions with a planned duration of 16-24 months. Upon completion of the clinical trial report, it will be submitted together with other materials for the application for listing registration in the China Food and Drug Administration (CFDA).

Eligibility criteria: Inclusion Criteria:

1. Older or equal to 18 years of age, regardless of sex.
2. Patients are able to understand the purpose of the trial, voluntarily participated in and signed informed consent, and are willing to complete the follow-up as required by the program.
3. Patients diagnosed with inferior deep vein thrombosis (inferior vena cava, Iliac, femoral or popliteal DVT) or pulmonary embolism (PE), and concomitant with one or more of the following situation:

   1. with the existence of contraindications for anticoagulation therapy.
   2. complications such as bleeding occurred during anticoagulation therapy.
   3. pulmonary embolism still recurred after adequate anticoagulation therapy.
   4. All reasons cannot achieve sufficient anticoagulant.
   5. PE coexist with inferior DVT.
   6. Free thrombosis or large amounts of thrombosis are found in the iliac, femoral, popliteal or inferior vena cava.
   7. Patients with acute risk factors of DVT and PE needed to undergo abdominal, pelvic or lower limb surgery simultaneously.
   8. The patients had acute DVT, intend to do Catheter-Directed Thrombolysis (CDT, Percutaneous Mechanical Thrombectomy (PMT), or surgical thrombectomy.
4. The investigator determined that the patient had an appropriate femoral or jugular access for implantation of the filter.
5. The diameter of inferior vena cava intended to implant the filter is between 18mm and 29mm.

Exclusion Criteria:

1. Had been implanted with an inferior vena cava filter previously.
2. There is thromboembolism in the jugular or femoral vein access of the filter implantation.
3. Intended to permanently implant the filter.
4. Severe spinal deformity may affect the implantation or removal of filters.
5. Renal vein thrombosis, or, inferior vena cava thrombosis spread to renal vein.
6. Congenital malformation of inferior vena cava.
7. Having an uncontrolled infectious disease, such as bacteremia or toxaemia.
8. Active malignant tumour and tumour metastasis.
9. Allergic to imaging agents, materials of filters and conveyor (including nickel and titanium, polyester, Polytetrafluoroethylene (PTFE), nylon polymer materials).
10. Patients with X-ray contraindication.
11. Liver dysfunction: Alanine transaminase (ALT) or Aspartate transaminase (AST) was 2.5 times higher than the normal upper limit, Serum creatinine (Cr) was two times higher than the normal upper limit.
12. Abnormal coagulation function in patients: activated part of thrombin time (APTT)10s more than the normal value.
13. Patients with a life expectancy less than 12 months.
14. Patients with severe heart and lung dysfunction.
15. Pregnant or lactating, or woman planned to be pregnant.
16. The patients participated in clinical trials of other drugs or medical devices and did not come out of the group or withdraw within the first 3 months of the screening period of this trial.

Primary outcomes:
measure: The clinical success rate of the filter implantation
timeFrame: 6 months after implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Liuzhou
country: China
facility: Liuzhou Worker's Hospital
state: Guangxi
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical College
state: Guizhou
city: Wuhan
country: China
facility: Union Hospital Tongji College Huazhong University of Science and Technology
state: Hubei
city: Jinan
country: China
facility: The Affiliated Hospital of Shandong University of TCM
state: Shandong
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjing Medical University General Hospital
state: Tianjin
city: Kunming
country: China
facility: Frist Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Ningbo
country: China
facility: Ningbo No.2 Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
Study officials:
affiliation: Peking University People's Hospital
name: Xiaoming Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: