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

  • STATUS
    Recruiting
  • End date
    Apr 15, 2023
  • participants needed
    120
  • sponsor
    Hangzhou Endonom Medtech Co., Ltd.
Updated on 5 March 2021

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.

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.

Details
Condition Type B Aortic Dissection
Treatment WeFlow-Tbranch Stent Graft System
Clinical Study IdentifierNCT04765605
SponsorHangzhou Endonom Medtech Co., Ltd.
Last Modified on5 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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: 1842mm
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 620mm
With proper femoral artery, iliac artery, and brachial artery access, endovascular treatment of the aorta can be performed

Exclusion Criteria

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]
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note