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Type B Aortic DissectionNCT04765605

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

A study testing WeFlow-Tbranch Stent Graft System in people with Type B Aortic Dissection, run by Hangzhou Endonom Medtech Co., Ltd. at 29 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Type B Aortic Dissection
What is being tested?
WeFlow-Tbranch Stent Graft System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
29 sitesChina
Study dates
25 Dec 2020to 25 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 to 80 years old, no gender limitation;
  • 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;
  • Diagnosed as Stanford type B aortic dissection and needed reconstruction of the left subclavian artery;
  • The diameter of the proximal anchoring area (the aorta at the posterior edge of the left common carotid artery) range: 18～42mm;
  • 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;
  • The distance between the left common carotid artery and the left subclavian artery ≥5mm;
  • 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
  • With proper femoral artery, iliac artery, and brachial artery access, endovascular treatment of the aorta can be performed.

Who cannot join

  • Pregnant, breastfeeding or cannot contraception during the trial period;
  • Participated in clinical trials of other drugs or devices during the same period;
  • 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;
  • Allergic to contrast agents, anesthetics, patches, and delivery materials;
  • Cannot tolerate anesthesia;
  • 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];
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  • True/false thoracic aortic aneurysm
  • History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
  • Contraindications to antiplatelet drugs and anticoagulants
  • Life expectancy is less than 12 months (such as advanced malignant tumors)
  • Acute systemic infection
  • Severe stenosis or calcification in the anchoring area at the proximal end of the stent, easily lead to the stent graft difficult adherent
  • Investigator judged that not suitable for interventional treatment.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

China29 sites

  • Chinese PLA General Hospital

    Beijing

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing

  • Xiangya Hospital of Central South University

    Changsha

  • West China Hospital of Sichuan University

    Chengdu

  • Foshan First People's Hospital

    Foshan

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou

  • First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou

  • Zhejiang Provincial People's Hospital

    Hangzhou

  • Anhui Provincial Hospital

    Hefei

  • Shandong Provincial Hospital

    Jinan

  • The First People's Hospital of Yunnan Province

    Kunming

  • Affiliated Hospital of Southwest Medical University

    Luzhou

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

  • Jiangsu Provincial People's Hospital

    Nanjing

  • Nanjing Gulou Hospital

    Nanjing

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

  • Shanghai Jiaotong University Affiliated Ninth People's Hospital

    Shanghai

  • The Second Affiliated Hospital of Naval Medical University

    Shanghai

  • Zhongshan Hospital, Fudan University

    Shanghai

  • The First Hospital of Hebei Medical University

    Shijia Zhuang

  • The First Affiliated Hospital of Soochow University

    Suzhou

  • Shanxi Bethune Hospital

    Taiyuan

  • Tianjin Chest Hospital

    Tianjin

  • Tianjin Medical University General Hospital

    Tianjin

  • The First Affiliated Hospital of PLA Air Force Military Medical University

    Xi'an

  • Yantai Yuhuangding Hospital

    Yantai

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

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.

Read the 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.

Being tested
WeFlow-Tbranch Stent Graft System
Keywords
Type B Aortic Dissection, proximal left subclavian artery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WeFlow-Tbranch Stent Graft SystemDevice

    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

Study groups in NCT04765605
Study groupRoleWhat they receive
WeFlow-Tbranch Stent Graft SystemExperimentalParticipants will be treated with WeFlow-Tbranch Stent Graft System
Receives: Device: WeFlow-Tbranch Stent Graft System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of no major adverse events within 30 days after surgery.

    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.

    Measured: 30 days after operation

  2. Treatment success rate of aortic dissection 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.

    Measured: 12 months after operation

Secondary outcomes (6)

  1. All-cause mortality, aortic dissection-related mortality, serious adverse events, device-related adverse events, incidence of left upper limb ischemia.

    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.

    Measured: 30 days, 6 months, and 12 months after operation

  2. The incidence of type I or type III endoleaks

    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.

    Measured: during operation, 30 days after operation, 6 months, 12 months

  3. Incidence of displacement of aorta and branch stent graft

    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.

    Measured: 6 months and 12 months after surgery

  4. Postoperative branch vessel patency rate

    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.

    Measured: 30 days, 6 months, 12 months after surgery

  5. Success rate of remodeling of aortic dissection

    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.

    Measured: 30 days, 6 months, 12 months after surgery

  6. Incidence of conversion to thoracotomy or secondary interventional surgery due to aortic dissection

    To evaluate whether the subject was converted to thoracotomy or secondary interventional surgery due to aortic dissection.

    Measured: immediately after the surgery, 30 days after operation, 6 months, 12 months, 2~5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start25 Dec 2020
  3. Primary completion25 Dec 2026 (estimated)
  4. Study completion25 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04765605
Sponsor's protocol ID
WeFlow001
Status last verified
Aug 2023
First submitted
4 Feb 2021
Last updated
30 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing WeFlow-Tbranch Stent Graft System in people with Type B Aortic Dissection, run by Hangzhou Endonom Medtech Co., Ltd. at 29 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of no major adverse events within 30 days after surgery. (time frame: 30 days after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04765605.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.

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