Percutaneous Endovascular Arch Repair Trial (PEART) Study

Hangzhou Endonom Medtech

Status: Enrolling

Conditions: Aortic Diseases

Treatments: Device: ZIPPER aortic arch stentgraft system

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05872282

ZIPPER V1.0

Details and patient eligibility

About

This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system

Full description

The feasible study of ZIPPER aortic arch stentgraft system is a prospective, multicenter, single arm trial, which will enroll a total of 24 patients. The goal of this study is to evaluate the safety and efficacy of ZIPPER aortic arch stentgraft system in the treatment of patients with aortic arch disease, included aortic arch dissections, aneurysms, residual dissection following ascending aorta surgical operation.

Enrollment: 24 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. Patients diagnosed with aortic arch disease requiring intervention, including non-A-non-B aortic dissection, or residual dissection after type A ascending aortic repair; aortic arch aneurysms.

3. Patients with suitable vascular conditions, including:

   1. Ascending aorta (including surgical graft) length greater than 30 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
   2. Proximal anchoring zone diameter ≥ 24 mm and ≤ 47 mm;
   3. Proximal anchoring zone length ≥ 20 mm;
   4. Innominate artery, left common carotid artery and left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
   5. 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. Evaluated by at least two investigators that the subjects are high-risk patients with more complications, poor general condition, high risk of deep hypothermic circulatory arrest, and not suitable for total arch replacement and other surgical procedures.

Exclusion criteria

1. Previously received open surgery or endovascular intervention for descending aorta or abdominal aorta;
2. Infectious aortic disease, takayasu arteritis, Marfan syndrome (or other connective tissue diseases );
3. Patients that have experienced systemic infection within past three months;
4. Neck surgery was performed within past three months;
5. Patients with severe stenosis, calcification, thrombosis or tortuosity in the brachiocephalic trunk, left common carotid artery or left subclavian artery;
6. Patients with intestinal necrosis and lower limb ischemic necrosis;
7. Paraplegic patients;
8. Heart transplant patients;
9. Patients that have suffered MI or stroke within past three months;
10. Patients with Class IV heart function (NYHA classification) or LVEF<30%
11. Active peptic ulcers or upper gastrointestinal bleeding occurring within the past three months;
12. Hematological abnormality, defined as follows: Leukopenia (WBC < 3 × 109/L), anemia (Hb < 90 g/L); coagulation dysfunction, thrombocytopenia (PLT count< 50 × 109/L);
13. Patients with renal insufficiency， serum creatinine > 150 umol/L (or 3.0 mg/dl) and / or end-stage renal disease requiring dialysis, shall be determined by the investigator after a comprehensive analysis;
14. Patients with severe liver dysfunction: ALT or AST exceeding 3 times the upper limit of norma, serum total bilirubin (STB) exceeds 2 times the upper limit of normal;
15. Patients who are allergic to contrast agents;
16. Patients that are pregnant or breastfeeding;
17. Patients with severe comorbidities who cannot tolerate anesthesia and surgery;
18. Patients with a life expectancy of less than 12 months;
19. Patients currently participating in other drug or device study;
20. The investigator assessed that the patient was ineligible for the study for other diseases or abnormalities.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

ZIPPER aortic arch stentgraft system

Experimental group

Treatment:

Device: ZIPPER aortic arch stentgraft system