Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)

Hangzhou Endonom Medtech

Status: Enrolling

Conditions: Aortic Arch Aneurysm

Treatments: Device: WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system

Study type: Interventional

Funder types: Industry

Identifiers

NCT06385379

WQ21-2301

Details and patient eligibility

About

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)

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system

Experimental group

Description:

Participants will be treated with WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system

Treatment:

Device: WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system