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Safety and Efficacy Study of Fitaya Vena Cava Filter

Primary Purpose

Venous Thromboembolism

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fitaya Vena Cava Filter System
Aegisy Vena Cava Filter
Sponsored by
Lifetech Scientific (Shenzhen) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thromboembolism focused on measuring Fitaya, Vena cava filter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Jishuitan HospitalRecruiting
  • Peking University People's HospitalRecruiting
  • Liuzhou Worker's HospitalRecruiting
  • Affiliated Hospital of Zunyi Medical CollegeRecruiting
  • Union Hospital Tongji College Huazhong University of Science and TechnologyRecruiting
  • The Affiliated Hospital of Shandong University of TCMRecruiting
  • Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of MedicineRecruiting
  • Second Hospital of Shanxi Medical UniversityRecruiting
  • Tianjin People's HospitalRecruiting
  • Tianjing Medical University General HospitalRecruiting
  • Frist Affiliated Hospital of Kunming Medical UniversityRecruiting
  • Ningbo No.2 HospitalRecruiting
  • Taizhou Hospital of Zhejiang ProvinceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental arm

Control arm

Arm Description

Patients will be treated with Fitaya Vena Cava Filter System.

Patients will be treated with Aegisy Vena Cava Filter.

Outcomes

Primary Outcome Measures

The clinical success rate of the filter implantation
The clinically successful implantation of vena cava filter should meet the following three requirements simultaneously: 1. The filter was successfully implanted and the shape and positioning were satisfactory. 2. No symptomatic pulmonary embolism occurred in patients with permanent filter implantation within 6 months after implantation and was confirmed by Computed Tomography Pulmonary Angiography (CTPA). No symptomatic pulmonary embolism occurred in patients who had a removal of the filter during its indwelling and was confirmed by CTPA. 3. No rupture, no displacement, no venous penetration, no vena occlusion, no filter implantation or operation-related deaths occurred in the blood vessels.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2018
Last Updated
February 14, 2020
Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03691753
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 29, 2018 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
Fitaya, Vena cava filter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Patients will be treated with Fitaya Vena Cava Filter System.
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Patients will be treated with Aegisy Vena Cava Filter.
Intervention Type
Device
Intervention Name(s)
Fitaya Vena Cava Filter System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Aegisy Vena Cava Filter
Intervention Description
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.
Primary Outcome Measure Information:
Title
The clinical success rate of the filter implantation
Description
The clinically successful implantation of vena cava filter should meet the following three requirements simultaneously: 1. The filter was successfully implanted and the shape and positioning were satisfactory. 2. No symptomatic pulmonary embolism occurred in patients with permanent filter implantation within 6 months after implantation and was confirmed by Computed Tomography Pulmonary Angiography (CTPA). No symptomatic pulmonary embolism occurred in patients who had a removal of the filter during its indwelling and was confirmed by CTPA. 3. No rupture, no displacement, no venous penetration, no vena occlusion, no filter implantation or operation-related deaths occurred in the blood vessels.
Time Frame
6 months after implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Older or equal to 18 years of age, regardless of sex. 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. 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: with the existence of contraindications for anticoagulation therapy. complications such as bleeding occurred during anticoagulation therapy. pulmonary embolism still recurred after adequate anticoagulation therapy. All reasons cannot achieve sufficient anticoagulant. PE coexist with inferior DVT. Free thrombosis or large amounts of thrombosis are found in the iliac, femoral, popliteal or inferior vena cava. Patients with acute risk factors of DVT and PE needed to undergo abdominal, pelvic or lower limb surgery simultaneously. The patients had acute DVT, intend to do Catheter-Directed Thrombolysis (CDT, Percutaneous Mechanical Thrombectomy (PMT), or surgical thrombectomy. The investigator determined that the patient had an appropriate femoral or jugular access for implantation of the filter. The diameter of inferior vena cava intended to implant the filter is between 18mm and 29mm. Exclusion Criteria: Had been implanted with an inferior vena cava filter previously. There is thromboembolism in the jugular or femoral vein access of the filter implantation. Intended to permanently implant the filter. Severe spinal deformity may affect the implantation or removal of filters. Renal vein thrombosis, or, inferior vena cava thrombosis spread to renal vein. Congenital malformation of inferior vena cava. Having an uncontrolled infectious disease, such as bacteremia or toxaemia. Active malignant tumour and tumour metastasis. Allergic to imaging agents, materials of filters and conveyor (including nickel and titanium, polyester, Polytetrafluoroethylene (PTFE), nylon polymer materials). Patients with X-ray contraindication. 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. Abnormal coagulation function in patients: activated part of thrombin time (APTT)10s more than the normal value. Patients with a life expectancy less than 12 months. Patients with severe heart and lung dysfunction. Pregnant or lactating, or woman planned to be pregnant. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Xia
Phone
+86 13760184511
Email
xiaying@lifetechmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoming Zhang, Professor
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Jishuitan Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianlong Liu
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoming Zhang
Facility Name
Liuzhou Worker's Hospital
City
Liuzhou
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peiyong Hou
Facility Name
Affiliated Hospital of Zunyi Medical College
City
Zunyi
State/Province
Guizhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongshu Shi
Facility Name
Union Hospital Tongji College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiqing Li
Facility Name
The Affiliated Hospital of Shandong University of TCM
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Dawei
Facility Name
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinwu Lu
Facility Name
Second Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Honglin Dong
Facility Name
Tianjin People's Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Li
Facility Name
Tianjing Medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangchen Dai
Facility Name
Frist Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Yang
Facility Name
Ningbo No.2 Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dehai Lang
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjun Zhao

12. IPD Sharing Statement

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Safety and Efficacy Study of Fitaya Vena Cava Filter

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