Safety and Efficacy Study of Fitaya Vena Cava Filter

NCT03691753 | Unknown DMC

• 1 other identifier: LT-01
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 13

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.

Conditions

Venous Thromboembolism

Keywords

Fitaya; Vena cava filter

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after implantation

Study Arms (2)

Experimental arm

EXPERIMENTAL

Patients will be treated with Fitaya Vena Cava Filter System.

Device: Fitaya Vena Cava Filter System

Control arm

ACTIVE COMPARATOR

Patients will be treated with Aegisy Vena Cava Filter.

Device: Aegisy Vena Cava Filter

Interventions

Fitaya Vena Cava Filter System DEVICE

After the implantation of Fitaya Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath.

Experimental arm

Aegisy Vena Cava Filter DEVICE

After the implantation of Aegisy Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath.

Control arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (13)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Liuzhou Worker's Hospital

Liuchow, Guangxi, China

RECRUITING

Affiliated Hospital of Zunyi Medical College

Zunyi, Guizhou, China

RECRUITING

Union Hospital Tongji College Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

The Affiliated Hospital of Shandong University of TCM

Jinan, Shandong, China

RECRUITING

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

RECRUITING

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Tianjing Medical University General Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Frist Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

RECRUITING

Ningbo No.2 Hospital

Ningbo, Zhejiang, China

RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xiaoming Zhang, Professor

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Xia

CONTACT

+86 13760184511; xiaying@lifetechmed.com

Study Design

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

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 2, 2018
• Study Start: September 29, 2018
• Primary Completion: April 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

CN (13)