Clinical trial NCT05754541: Guo's Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: a Multicenter Pilot Study(GRAFT Study)
Official title: Guo's Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: a Multicenter Pilot Study(Graft Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Aneurysm and Dissection
Keywords: Stent Graft
Lead sponsor: Hangzhou Endonom Medtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-06
Enrollment: 20
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: To explore the effect and prognosis of endovascular interventional therapy in high-risk patients with aortic arch dissection and aneurysm

Detailed description: The WeFlow-Tribranch Aortic Arch Stent Graft System first in man study is a prospective, multi-center, single arm trial, which will enroll a total of 20 patients. The goal of this study is to evaluate the safety and efficacy of WeFlow-Tribranch Aortic Arch Stent Graft System in the treatment of patients with aortic arch dissection and aneurysm.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 to 80 years old.
2. The patient was diagnosed with subacute or chronic aortic arch dissection, or Aortic arch aneurysms.
3. Patients showing a suitable vascular condition, including:

   1. Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
   2. Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
   3. Proximal anchoring zone length ≥ 30 mm;
   4. Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
   5. Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
   6. Suitable arterial access for endovascular interventional treatment ;
4. Patients able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
5. Patients evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications. (The recommended reference criteria are: EuroSCORE score ≥ 6, or CFS score \> 4, or ASA grade 3-4, or there are other high-risk surgical factors that affect the prognosis of the subject, such as patients with a history of open surgery, other high-risk factors judged by a physician team, or patients who refuse open surgery.)

Exclusion Criteria:

1. Patients that have experienced systemic infection during past three months;
2. Neck surgery was performed within three months;
3. Infectious aortic disease、Takayasu arteritis，Marfan syndrome (or other connective tissue diseases );
4. Patients with severe stenosis, calcification, thrombosis or tortuosity of the Brachiocephalic trunk, Left common carotid artery or left subclavian artery;
5. Heart transplant patients;
6. Patients that have suffered MI or stroke during past three months;
7. Patients with Class IV heart function (NYHA classification) or LVEF\<30%
8. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;
9. Hematological abnormality, defined as follows: Leukopenia (WBC \< 3 × 109/L), acute anemia (Hb \< 90 g/L); thrombocytopenia (PLT count \< 50 × 109/L);
10. Patients with renal insufficiency， serum creatinine \> 150 umol/l (or 3.0 mg/dl) and / or end-stage renal disease requiring renal dialysis shall be determined by the investigator after comprehensive analysis;
11. Subjects with severe liver dysfunction and ALT or AST exceeding 3 times the upper limit of normal; Subjects whose serum total bilirubin (STB) exceeds 2 times the upper limit of normal;
12. Patients with intestinal necrosis and lower limb ischemic necrosis;
13. Paraplegic patients;
14. Patients that are pregnant or breastfeeding;
15. Patients with allergies to contrast agents;
16. Patients with a life expectancy of less than 12 months;
17. Patients currently participating in other drug or device research;
18. Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.

Primary outcomes:
measure: All-cause mortality and major stroke within 12 months after surgery.
timeFrame: 12 months post-intervention
Secondary outcomes:
measure: Aortic-related mortality within 12 months post operation.
timeFrame: within 12 months post operation
measure: Aortic remodeling results.
timeFrame: 1 month, 6 months and 12 months post-intervention
measure: Major adverse events occurring within 30 days after surgery.
timeFrame: within 30 days after surgery
measure: Incidence of severe adverse events.
timeFrame: within 12 months post-intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA Gencral Hosptial
state: Beijing
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: Chinese PLA Gencral Hosptial
name: wei Guo
role: PRINCIPAL_INVESTIGATOR
References: