Percutaneous Endovascular Arch Repair Trial (PEART) Study

NCT ID: NCT05872282

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-28
• Study Completion Date: 2025-04-28

Brief Summary

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

Detailed 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.

Conditions

Aortic Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ZIPPER aortic arch stentgraft system

Group Type: EXPERIMENTAL

ZIPPER aortic arch stentgraft system

Intervention Type: DEVICE

The ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system.

Interventions

ZIPPER aortic arch stentgraft system

The ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne W.Zhang , Seattle，Washington，USA

UNKNOWN

Sponsor Role: collaborator

Hangzhou Endonom Medtech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wayne W. Zhang

Role: PRINCIPAL_INVESTIGATOR

Seattle，Washington，USA

Weiguo Fu

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Jia Hu

Chengdu, , China

Site Status: NOT_YET_RECRUITING

Weiguo Fu

Shanghai, , China

Site Status: RECRUITING

Honglin Dong

Taiyuan, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Wayne W. Zhang

Role: CONTACT

wwzhang08@gmail.com

Weiguo Fu

Role: CONTACT

fu.weiguo@zs-hospital.sh.cn

13801760929

Facility Contacts

Jia Hu

Role: primary

1725194@qq.com

Weiguo Fu

Role: primary

fu.weiguo@zs-hospital.sh.cn

Honglin Dong

Role: primary

honglindong@sxmu.edu.cn

Other Identifiers

ZIPPER V1.0

Identifier Type: -

Identifier Source: org_study_id