Safety and Efficacy Study Of The Thoracic Aortic Stent Graft System Treating Aortic Dissection

June 19, 2022 updated by: Zhejiang Zylox Medical Device Co., Ltd.

A Prospective, Multicenter, Objective Performance Criteria-Controlled Study for National Medical Products Administration Approval Of The Thoracic Aortic Stent Graft System

This is a prospective, multicenter and single-arm trail to study the safety and efficacy of the thoracic aortic stent graft system that specially designed for treating aortic dissection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This trail is conducted in several centers all around China. In about 18 months, 120 subjects with aortic dissection will be recruited, all of which receive endovascular treatment using the thoracic aortic stent graft system (Zylox-Tonbridge Medical Technology Co., Ltd. ). The subjects will be followed up in 30 days/ 6 months/ 12 months/ 2-5 years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking Union Medical College Hospital
      • Shanghai, China
        • Zhongshan Hospital
      • Shanghai, China
        • Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
    • Anhui
      • Bengbu, Anhui, China
        • The First Affiliated Hospital of Bengbu Medical College
        • Principal Investigator:
          • Chaowen Yu
      • Hefei, Anhui, China
        • The Second Hospital of Anhui Medical University
    • Guangxi
      • Liuzhou, Guangxi, China
        • Liuzhou Worker's Hospital
        • Principal Investigator:
          • Peiyong Hou
    • Henan
      • Kaifeng, Henan, China
        • Huaihe Hospital of Henan University
        • Principal Investigator:
          • Jianbo Che
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Zhengzhou University
        • Principal Investigator:
          • Zhiwei Wang
    • Hubei
      • Wuhan, Hubei, China
        • Renmin Hospital of Wuhan University
        • Principal Investigator:
          • Hongping Deng
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The Second Affiliated Hospital of Nanchang University
    • Shaanxi
      • Xi'an, Shaanxi, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Principal Investigator:
          • Jianlin Liu
    • Zhejiang
      • Hanzhou, Zhejiang, China
        • The First Hospital of Zhejiang Province
      • Wenzhou, Zhejiang, China
        • The First Affiliated Hospital of WMU
        • Principal Investigator:
          • Jingyong Huang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 80 years;
  • Subject or legal representative is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent；
  • Subjects who are diagnosed with Stanford type B aortic dissection requiring reconstruction of the left common carotid artery and left subclavian artery or requiring reconstruction of the left subclavian artery;
  • Appropriate access to the femoral artery, iliac artery, brachial artery, etc. that can be used for endoluminal aortic therapy.

Exclusion Criteria:

  • The same surgery requires intervention for other vascular lesions；
  • History of surgery in the aortic arch or endovascular repair surgery;
  • Severe stenosis or calcification or distortion in the anchoring area of the proximal end of the stent;
  • Subjects with severe liver, kidney failure；
  • Subjects with severe coagulation disorders；
  • Female subjects who are pregnant, lactating within the study period or unable to contraception during the trail.
  • History of allergies to anesthetics, contrast agents or the material of stent/ deliver system；
  • Inability to tolerate anesthesia；
  • History of acute myocardial infarction, cerebral infarction or cerebral hemorrhage within 3 months before surgery;
  • Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint.
  • Subjects with acute systemic infection
  • Other circumstances judged by researchers that are not suitable for enrollment .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Subjects with aortic dissection
Subjects receive endovascular treatment.
Device: The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. )
This is a objective performance criteria-controlled study, all subjects meet the criteria will receive the same treatment using the thoracic aortic stent graft system (Zylox-Tonbridge Medical Technology Co., Ltd. ).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of no Major Adverse Event (MAE)
Time Frame: Immediately after the intervention
MAE was defined as aortic dissection related death, disabling stoke or paraplegic.
Immediately after the intervention
Rate of no Major Adverse Event (MAE)
Time Frame: 30 days
MAE was defined as aortic dissection related death, disabling stoke or paraplegic.
30 days
Success rate of endovascular treatment
Time Frame: Up to 12 months
  • Technique success: the delivery system was successfully delivered to the predetermined position, the stent was accurately positioned and successfully deployed, and the delivery system could be safely withdrawn from the body, no type I or type III endoleak can be found during angiography.
  • No stent displacement during 12 months follow up time.
  • No secondary surgical intervention during 12 months follow up.
Up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of aortic dissection related mortality
Time Frame: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Death caused by aortic dissection rupture or related treatment.
Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of all cause mortality
Time Frame: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Death for any reason will be recorded.
Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of Adverse Events(AE)
Time Frame: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
The definition of AE(Adverse Event) refers to International Organization for Standardization (ISO) 14155, AE should be distinguished from normal postoperative stress response.
Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of Serious Adverse Events(SAE)
Time Frame: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
The definition of SAE (Serious Adverse Event) refers to ISO 14155.
Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of technique success
Time Frame: Immediately after the intervention
The delivery system was successfully delivered to the predetermined position, the stent was accurately positioned and successfully deployed, and the delivery system could be safely withdrawn from the body, no type I or type III endoleak can be found during angiography.
Immediately after the intervention
Incidence of stent displacement
Time Frame: 30 days/ 6 months/ 12 months
Stent displacement was defined as the aortic and branch stent-grafts displacing by more than 10 mm from the post-implantation position.
30 days/ 6 months/ 12 months
Success rate of endovascular repair
Time Frame: 30 days/ 6 months/ 12 months
Comparison of CTA results before surgery and within 30 days, 6 months, and 12 months after surgery. Changes in the diameter of the stent covered by aortic dissection and thrombosis of the false lumen are used to determine whether the vessel is successfully repaired.
30 days/ 6 months/ 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang Zylox Medical Device Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xinwu Lu, Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V1.1/2021-11-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings