Guo's Subclavian Artery Reconstruction: The Prospective, Multiple Center Study of WeFlow-Tbranch Stent Graft System(GUEST Study)

April 28, 2024 updated by: Hangzhou Endonom Medtech Co., Ltd.
This study is a prospective, multiple center study to evaluate the safety and effectiveness of WeFlow-Tbranch single embedded branch thoracic aorta stent graft system manufactured by EndoNom Medtech (Hangzhou) Co., Ltd.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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 study is a prospective, multiple center study to evaluate the safety and effectiveness of WeFlow-Tbranch single embedded branch thoracic aorta stent graft system in the treatment of Stanford type B dissection of the proximal left subclavian artery. It is expected to complete the implantation of 120 patients in 29 centers within 12 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24 months postoperatively, 36 months postoperatively, 48 months postoperatively and 60 months postoperatively.

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 (Actual)

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
        • Chinese PLA General Hospital
      • Beijing, China
        • Fuwai Hospital, Chinese Academy of Medical Sciences
      • Changsha, China
        • Xiangya Hospital of Central South University
      • Chengdu, China
        • West China Hospital of Sichuan University
      • Foshan, China
        • Foshan First People's Hospital
      • Fuzhou, China
        • The First Affiliated Hospital of Fujian Medical University
      • Guangzhou, China
        • The First Affiliated Hospital of Sun Yat-sen University
      • Hangzhou, China
        • Zhejiang Provincial People's Hospital
      • Hangzhou, China
        • First Affiliated Hospital of Zhejiang University School of Medicine
      • Hefei, China
        • Anhui Provincial Hospital
      • Jinan, China
        • Shandong Provincial Hospital
      • Kunming, China
        • The First People's Hospital of Yunnan Province
      • Luzhou, China
        • Affiliated Hospital of Southwest Medical University
      • Nanchang, China
        • The Second Affiliated Hospital of Nanchang University
      • Nanjing, China
        • Jiangsu Provincial People's Hospital
      • Nanjing, China
        • Nanjing Gulou Hospital
      • Nanning, China
        • The First Affiliated Hospital of Guangxi Medical University
      • Shanghai, China
        • Zhongshan hospital, Fudan university
      • Shanghai, China
        • Renji Hospital, Shanghai Jiaotong University School of Medicine
      • Shanghai, China
        • Shanghai Jiaotong University Affiliated Ninth People's Hospital
      • Shanghai, China
        • The Second Affiliated Hospital of Naval Medical University
      • Shijia Zhuang, China
        • The First Hospital of Hebei Medical University
      • Suzhou, China
        • The First Affiliated Hospital of Soochow University
      • Taiyuan, China
        • Shanxi Bethune Hospital
      • Tianjin, China
        • Tianjin Medical University General Hospital
      • Tianjin, China
        • Tianjin Chest Hospital
      • Xian, China
        • The First Affiliated Hospital of PLA Air Force Military Medical University
      • Yantai, China
        • Yantai YuHuangDing Hospital
      • Zhengzhou, China
        • First Affiliated Hospital of Zhengzhou University

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

Description

Inclusion Criteria:

  1. Patients aged 18 to 80 years old, no gender limitation;
  2. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol;
  3. Diagnosed as Stanford type B aortic dissection and needed reconstruction of the left subclavian artery;
  4. The diameter of the proximal anchoring area (the aorta at the posterior edge of the left common carotid artery) range: 18～42mm;
  5. The length of the proximal anchoring area (the distance from the rear edge of the left common carotid artery opening to the first breach) ≥15mm;
  6. The distance between the left common carotid artery and the left subclavian artery ≥5mm;
  7. The distance between the left vertebral artery and the opening of the left subclavian artery is ≥15mm, the diameter of the starting part of the left subclavian artery is 6～20mm
  8. With proper femoral artery, iliac artery, and brachial artery access, endovascular treatment of the aorta can be performed.

Exclusion Criteria:

  1. Pregnant, breastfeeding or cannot contraception during the trial period;
  2. Participated in clinical trials of other drugs or devices during the same period;
  3. The same operation requires intervention in other vascular diseases (such as coronary artery, renal artery, superior mesenteric artery, etc.), and the postoperative drug treatment plan is therefore affected;
  4. Allergic to contrast agents, anesthetics, patches, and delivery materials;
  5. Cannot tolerate anesthesia;
  6. Severe liver, kidney, lung, and heart function abnormalities before surgery [Serum creatinine exceeds 2 times the upper limit of normal; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper limit of normal; Serum total bilirubin (STB) more than 2 times the upper limit of normal; Left ventricular ejection fraction is lower than normal by cardiac color Doppler ultrasound examination];
  7. True/false thoracic aortic aneurysm
  8. History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
  9. Contraindications to antiplatelet drugs and anticoagulants
  10. Life expectancy is less than 12 months (such as advanced malignant tumors)
  11. Acute systemic infection
  12. Severe stenosis or calcification in the anchoring area at the proximal end of the stent, easily lead to the stent graft difficult adherent
  13. Investigator judged that not suitable for interventional treatment.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Experimental: WeFlow-Tbranch Stent Graft System
Participants will be treated with WeFlow-Tbranch Stent Graft System
Device: WeFlow-Tbranch Stent Graft System
The single-embedded branch thoracic aorta stent graft system consists of the thoracic aorta stent graft system and the branch stent system. The main chest embedded stent graft system consists of the main chest embedded stent graft and its system conveyor, and the branch stent system consists of branch stents and its conveyor. The main chest embedded stent graft and the branch stent are pre-installed in the conveyor

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 events within 30 days after surgery.
Time Frame: 30 days after operation
Major adverse events within 30 days after operation refer to all-cause death, myocardial infarction, ischemic stroke, respiratory failure, liver failure, renal failure, intestinal necrosis, paraplegia, and amputation within 30 days after operation. Among them, renal failure refers to long-lasting dialysis, kidney transplantation, or other fatal results. Intestinal necrosis is intestinal ischemia that requires bowel resection or other fatal consequences. Severe lower limb ischemia refers to new severe limp or resting pain after surgery.
30 days after operation
Treatment success rate of aortic dissection 12 months after operation
Time Frame: 12 months after operation
The success rate of aortic dissection treatment at 12 months is a composite index, including immediate technical success after surgery and no displacement of the aorta and branch stent grafts in CTA 12 months after surgery, and no type I and type III endoleaks, the branch stent was unobstructed, and no second surgical intervention occurred during the follow-up period.
12 months after operation

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
All-cause mortality, aortic dissection-related mortality, serious adverse events, device-related adverse events, incidence of left upper limb ischemia.
Time Frame: 30 days, 6 months, and 12 months after operation
  1. All-cause mortality 30 days, 6 months, and 12 months after operation.
  2. Mortality related to aortic dissection 30 days, 6 months, and 12 months after operation.
  3. Incidence of serious adverse events 30 days, 6 months, and 12 months after operation.
  4. The incidence of device-related adverse events 30 days, 6 months, and 12 months after operation.
  5. Incidence of left upper limb ischemia 30 days, 6 months, and 12 months after operation.
30 days, 6 months, and 12 months after operation
The incidence of type I or type III endoleaks
Time Frame: during operation, 30 days after operation, 6 months, 12 months
Record the endoleaks shown in the postoperative DSA or CTA images. Intraoperative endoleaks and adjuvant treatment are not recorded. Endoleaks that occurred after the completion of the operation and those that were not treated in the same subject at different follow-up stages were counted once.
during operation, 30 days after operation, 6 months, 12 months
Incidence of displacement of aorta and branch stent graft
Time Frame: 6 months and 12 months after surgery
Observe and record CTA at 6 months and 12 months after operation to check the stent displacement, the main stent and branch stents are recorded and evaluated. Displacement was defined as the displacement of the node aorta and branch stent grafts by more than 10 mm compared to the 30th day after surgery.
6 months and 12 months after surgery
Postoperative branch vessel patency rate
Time Frame: 30 days, 6 months, 12 months after surgery
Observe and record CTA on the 30th day, 6 months, and 12 months after operation to evaluate the revascularization of branch vessels, whether there is occlusion, stenosis or thrombosis in the stent. Postoperative branch vessel stenosis ≤50% is considered unobstructed.
30 days, 6 months, 12 months after surgery
Success rate of remodeling of aortic dissection
Time Frame: 30 days, 6 months, 12 months after surgery
Compare the results of CTA before operation and on the 30th day, 6th month and 12th month after operation, the expansion of the true lumen and the thrombosis of the false lumen at the coverage of the aortic dissection vascular stent to determine whether the blood vessel is successfully remodeled.
30 days, 6 months, 12 months after surgery
Incidence of conversion to thoracotomy or secondary interventional surgery due to aortic dissection
Time Frame: immediately after the surgery, 30 days after operation, 6 months, 12 months, 2~5 years
To evaluate whether the subject was converted to thoracotomy or secondary interventional surgery due to aortic dissection.
immediately after the surgery, 30 days after operation, 6 months, 12 months, 2~5 years

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.
Hangzhou Endonom Medtech 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: Wei Guo, Professor, Chinese PLA General Hospital

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 (Actual)

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.
December 25, 2020

Primary Completion (Estimated)

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.
December 25, 2026

Study Completion (Estimated)

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.
December 25, 2026

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).
February 4, 2021

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.
February 19, 2021

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.
February 21, 2021

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.
April 30, 2024

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.
April 28, 2024

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.
August 1, 2023

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.
  • WeFlow001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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