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)

Overview

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.

Interventions

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

Primary outcome measures

• Rate of all-cause mortality and major stroke within 12 months after surgery [Time frame: 12 months after surgery]

Secondary outcome measures (10)

• Rate of immediate technical success following surgery [Time frame: immediately after the surgery]
• Rate of aortic aneurysm progression under control [Time frame: 12 months after operation]
• Incidence of Type I or Type III endoleak [Time frame: during operation and at 1, 6, and 12 months after operation]
• Incidence of aortic covered stent graft displacement [Time frame: 6 months, 12 months after operation]
• Postoperative branch vessel patency rate [Time frame: 1 month, 6 months, 12 months after operation]
• Rate of conversion to thoracotomy or secondary intervention [Time frame: 30 days, 6 months, and 12 months after operation]
• Rate of major adverse events [Time frame: 30 days after surgery]
• Rate of aortic aneurysm-related mortality [Time frame: 12 months after operation]
• Incidence of severe adverse events [Time frame: 30 days, 6 months, and 12 months after operation]
• Incidence of device-related adverse events [Time frame: 30 days, 6 months, and 12 months after operation]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 20 centers

• Beijing Anzhen Hospital, Capital Medical University — Beijing
• Chinese PLA Gencral Hosptial — Beijing
• The First Hospital of Jilin University — Changchun
• Xiangya Hospital of Central South University — Changsha
• West China Hospital of Sichuan University — Chengdu
• Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou
• The First Affiliated Hospital ,Sun Yat-sen University — Guangzhou
• The First Affiliated Hospital of Harbin Medical University — Harbin
• … and 12 more centers

Identifiers

NCT: NCT06385379 · WQ21-2301

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗