Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
186 participants
INTERVENTIONAL
2018-09-29
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental arm
Patients will be treated with Fitaya Vena Cava Filter System.
Fitaya Vena Cava Filter System
After the implantation of Fitaya Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath.
Control arm
Patients will be treated with Aegisy Vena Cava Filter.
Aegisy Vena Cava Filter
After the implantation of Aegisy Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath.
Interventions
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Fitaya Vena Cava Filter System
After the implantation of Fitaya Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath.
Aegisy Vena Cava Filter
After the implantation of Aegisy Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Lifetech Scientific (Shenzhen) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaoming Zhang, Professor
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Liuzhou Worker's Hospital
Liuzhou, Guangxi, China
Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, China
Union Hospital Tongji College Huazhong University of Science and Technology
Wuhan, Hubei, China
The Affiliated Hospital of Shandong University of TCM
Jinan, Shandong, China
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
Tianjing Medical University General Hospital
Tianjin, Tianjin Municipality, China
Frist Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Ningbo No.2 Hospital
Ningbo, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Jianlong Liu
Role: primary
Xiaoming Zhang
Role: primary
Peiyong Hou
Role: primary
Rongshu Shi
Role: primary
Yiqing Li
Role: primary
Zhang Dawei
Role: primary
Xinwu Lu
Role: primary
Honglin Dong
Role: primary
Li Li
Role: primary
Xiangchen Dai
Role: primary
Bin Yang
Role: primary
Dehai Lang
Role: primary
Wenjun Zhao
Role: primary
Other Identifiers
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LT-01
Identifier Type: -
Identifier Source: org_study_id
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