Guo's Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: a Multicenter Pilot Study(GRAFT Study)

Hangzhou Endonom Medtech

Status: Enrolling

Conditions: Aortic Aneurysm and Dissection

Treatments: Device: WeFlow-Tribranch Aortic Arch Stent Graft System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05754541

WeFlow-Tribranch V1.0

Details and patient eligibility

About

To explore the effect and prognosis of endovascular interventional therapy in high-risk patients with aortic arch dissection and aneurysm

Full 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.

Enrollment: 20 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. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

WeFlow-Tribranch Aortic Arch Stent Graft System

Experimental group

Treatment:

Device: WeFlow-Tribranch Aortic Arch Stent Graft System