Clinical trial NCT06385379: Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)
Official title: Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch Unique Embedded Aortic Triple-branch Arch Stent Graft System (GENIUS Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Arch Aneurysm
Lead sponsor: Hangzhou Endonom Medtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Detailed description: This study is a prospective ,multiple center study about the safety and efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System , it is expected to complete the implantation of 90 patients in 20 centers within 20 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 24th month, 36th month, 48th month and 60th month postoperatively.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of all-cause mortality and major stroke within 12 months after surgery
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Rate of immediate technical success following surgery
timeFrame: immediately after the surgery
measure: Rate of aortic aneurysm progression under control
timeFrame: 12 months after operation
measure: Incidence of Type I or Type III endoleak
timeFrame: during operation and at 1, 6, and 12 months after operation
measure: Incidence of aortic covered stent graft displacement
timeFrame: 6 months, 12 months after operation
measure: Postoperative branch vessel patency rate
timeFrame: 1 month, 6 months, 12 months after operation
measure: Rate of conversion to thoracotomy or secondary intervention
timeFrame: 30 days, 6 months, and 12 months after operation
measure: Rate of major adverse events
timeFrame: 30 days after surgery
measure: Rate of aortic aneurysm-related mortality
timeFrame: 12 months after operation
measure: Incidence of severe adverse events
timeFrame: 30 days, 6 months, and 12 months after operation
measure: Incidence of device-related adverse events
timeFrame: 30 days, 6 months, and 12 months after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
city: Beijing
country: China
facility: Chinese PLA Gencral Hosptial
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
city: Guangzhou
country: China
facility: The First Affiliated Hospital ,Sun Yat-sen University
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
city: Jinan
country: China
facility: Shandong Provincial Hospital
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
city: Nanchang
country: China
facility: The Second Affiliated Hospital Of Nanchang University
city: Nanjing
country: China
facility: Nanjing First Hospital
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
city: Qingdao
country: China
facility: The Affiliated Hospital Of Qingdao University
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital
city: Xian
country: China
facility: The First Affiliated Hospital of PLA Air Force Military Medical University
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
Study officials:
References: