Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)
1 other identifier
interventional
90
1 country
20
Brief Summary
A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2024
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2024
CompletedFirst Posted
Study publicly available on registry
April 26, 2024
CompletedStudy Start
First participant enrolled
June 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
ExpectedMay 1, 2026
April 1, 2026
1.5 years
April 22, 2024
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of all-cause mortality and major stroke within 12 months after surgery
All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes. Severe stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days following stroke onset.
12 months after surgery
Secondary Outcomes (10)
Rate of immediate technical success following surgery
immediately after the surgery
Rate of aortic aneurysm progression under control
12 months after operation
Incidence of Type I or Type III endoleak
during operation and at 1, 6, and 12 months after operation
Incidence of aortic covered stent graft displacement
6 months, 12 months after operation
Postoperative branch vessel patency rate
1 month, 6 months, 12 months after operation
- +5 more secondary outcomes
Study Arms (1)
WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
EXPERIMENTALParticipants will be treated with WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
Interventions
The WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system, the aortic extension stent graft system and the branch stent system.
Eligibility Criteria
You may qualify if:
- Patients aged 18 to 80 years old;
- Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;
- 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;
- 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.
- 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.
You may not qualify if:
- Experienced systemic infection during past three months;
- Neck surgery was performed within 3 months;
- Previous endovascular interventional treatment involving the aortic arch was performed;
- Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases );
- Severe stenosis, calcification, thrombosis, or tortuosity of the branch artery to be reconstructed;
- Heart transplant;
- Suffered Myocardial Infarction or Stroke during past three months;
- Class IV heart function (NYHA classification);
- Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;
- Hematological abnormality, defined as follows: Leukopenia (WBC \< 3 ×109/L), acute anemia (Hb \< 90 g/L), Coagulation disorders, thrombocytopenia (PLT count \< 50 × 109/L);
- Renal insufficiency, creatinine \> 150 umol/L and/or end-stage renal disease requiring renal dialysis;
- Pregnant or breastfeeding;
- Allergies to contrast agents;
- Life expectancy of less than 12 months;
- Participating in another drug or device research;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Chinese PLA Gencral Hosptial
Beijing, China
The First Hospital of Jilin University
Changchun, China
Xiangya Hospital of Central South University
Changsha, China
West China Hospital of Sichuan University
Chengdu, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, China
The First Affiliated Hospital ,Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital of Harbin Medical University
Harbin, China
Shandong Provincial Hospital
Jinan, China
The First People's Hospital of Yunnan Province
Kunming, China
The Second Affiliated Hospital Of Nanchang University
Nanchang, China
Nanjing First Hospital
Nanjing, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
The Affiliated Hospital Of Qingdao University
Qingdao, China
Shanghai Chest Hospital
Shanghai, China
Zhongshan Hospital, Fudan University
Shanghai, China
The First Affiliated Hospital of China Medical University
Shenyang, China
The First Affiliated Hospital of PLA Air Force Military Medical University
Xi'an, China
Xiamen Cardiovascular Hospital
Xiamen, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2024
First Posted
April 26, 2024
Study Start
June 30, 2024
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2030
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- It is expected that data will be obtained after study completion for at least one year.
The data will be shared for scientific purposes after the completion of the clinical trial. However, patients' electronic records and any CTA files are outside the scope of our data sharing policy. Researchers wanting to request data can submit a detailed application to the investigators. Data will be released depending on the scientific quality of the submitted request.