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New stent aims to fix deadly aortic aneurysms without open surgery

NCT ID NCT06385379

Disease control Sponsor: Hangzhou Endonom Medtech Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device called the WeFlow-Tribranch stent graft system to repair aneurysms or ulcers in the aortic arch. About 90 people aged 18 to 80 with these conditions will receive the stent through a minimally invasive procedure. The main goal is to see if the device is safe and effective by measuring survival and freedom from major stroke within 12 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients aged 18 to 80 years old; 2. Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch; 3. Showing a suitable vascular condition, including: * Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery). * Ascending aorta diameter ≥ 24 mm and ≤ 48 mm; * Proximal anchoring zone length ≥ 30 mm; * Branch arteries to be reconstructed were ≤ 24 mm and ≥ 6 mm in diameter and ≥ 20 mm in length; * Suitable arterial access for endovascular interventional treatment; 4. 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. 5. Subjects were assessed as high risk for surgery by at least two investigators or judged to have significant surgical contraindications. Recommended reference criteria were a European system for cardiac operative risk evaluation (EuroScore) score of 6 or higher or other surgical risk factors as judged by the physician team. Exclusion Criteria: 1. Experienced systemic infection during past three months; 2. Neck surgery was performed within 3 months; 3. Previous endovascular interventional treatment involving the aortic arch was performed; 4. Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases ); 5. Severe stenosis, calcification, thrombosis, or tortuosity of the branch artery to be reconstructed; 6. Heart transplant; 7. Suffered Myocardial Infarction or Stroke during past three months; 8. Class IV heart function (NYHA classification); 9. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months; 10. Hematological abnormality, defined as follows: Leukopenia (WBC \< 3 ×109/L), acute anemia (Hb \< 90 g/L), Coagulation disorders, thrombocytopenia (PLT count \< 50 × 109/L); 11. Renal insufficiency, creatinine \> 150 umol/L and/or end-stage renal disease requiring renal dialysis; 12. Pregnant or breastfeeding; 13. Allergies to contrast agents; 14. Life expectancy of less than 12 months; 15. Participating in another drug or device research; 16. Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.

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Conditions

The condition(s) this trial relates to.

Aneurysm, Aortic Arch thoracic aortic aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic arch aneurysm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Anzhen Hospital, Capital Medical University

    RECRUITING

    Beijing, China

  • Chinese PLA Gencral Hosptial

    RECRUITING

    Beijing, China

  • First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, China

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    RECRUITING

    Guangzhou, China

  • Nanjing First Hospital

    RECRUITING

    Nanjing, China

  • Shandong Provincial Hospital

    RECRUITING

    Jinan, China

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, China

  • The Affiliated Hospital Of Qingdao University

    RECRUITING

    Qingdao, China

  • The First Affiliated Hospital ,Sun Yat-sen University

    RECRUITING

    Guangzhou, China

  • The First Affiliated Hospital of China Medical University

    RECRUITING

    Shenyang, China

  • The First Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, China

  • The First Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, China

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

    RECRUITING

    Xi'an, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, China

  • The First People's Hospital of Yunnan Province

    RECRUITING

    Kunming, China

  • The Second Affiliated Hospital Of Nanchang University

    RECRUITING

    Nanchang, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, China

  • Xiamen Cardiovascular Hospital

    RECRUITING

    Xiamen, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Changsha, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, China

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