Percutaneous Endovascular Arch Repair Trial (PEART) Study

NCT05872282 | Unknown

• 1 other identifier: ZIPPER V1.0
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Aortic Diseases

Keywords

Aortic Arch; Dissection; aneurysm

Outcome Measures

Primary Outcomes (1)

• Freedom from major device/procedure-related adverse events within 30 days post-operation.

  Device or procedure related major adverse events included: stroke, respiratory failure, pericardial tamponade, dissection or aneurysm rupture, paraplegia, stent occlusion, fracture, migration, access vessel thrombosis or rupture, conversion to open surgery, death.

  30 days after intervention

Secondary Outcomes (11)

• Immediate postoperative technical success.

  immediately after intervention

• Incidence of Type I or Type III endoleaks.

  1 month, 6 months and 12 months post-intervention

• Incidence of aortic arch stent graft migration.

  1 month, 6 months and 12 months post-intervention

• Postoperative branch vessel patency rate.

  1 month, 6 months and 12 months post-intervention

• Results of aortic remodeling after aortic dissection surgery

  1 month, 6 months and 12 months post-intervention

Study Arms (1)

ZIPPER aortic arch stentgraft system

EXPERIMENTAL

Device: ZIPPER aortic arch stentgraft system

Interventions

ZIPPER aortic arch stentgraft system 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.

ZIPPER aortic arch stentgraft system

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 80 years old
• 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.
• Patients with suitable vascular conditions, including:
• Ascending aorta (including surgical graft) length greater than 30 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
• Proximal anchoring zone diameter ≥ 24 mm and ≤ 47 mm;
• Proximal anchoring zone length ≥ 20 mm;
• Innominate artery, left common carotid artery and left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
• Suitable arterial access for endovascular interventional treatment;
• 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.
• 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.

You may not qualify if:

• Previously received open surgery or endovascular intervention for descending aorta or abdominal aorta;
• Infectious aortic disease, takayasu arteritis, Marfan syndrome (or other connective tissue diseases );
• Patients that have experienced systemic infection within past three months;
• Neck surgery was performed within past three months;
• Patients with severe stenosis, calcification, thrombosis or tortuosity in the brachiocephalic trunk, left common carotid artery or left subclavian artery;
• Patients with intestinal necrosis and lower limb ischemic necrosis;
• Paraplegic patients;
• Heart transplant patients;
• Patients that have suffered MI or stroke within past three months;
• Patients with Class IV heart function (NYHA classification) or LVEF\<30%
• Active peptic ulcers or upper gastrointestinal bleeding occurring within the past three months;
• Hematological abnormality, defined as follows: Leukopenia (WBC \< 3 × 109/L), anemia (Hb \< 90 g/L); coagulation dysfunction, thrombocytopenia (PLT count\< 50 × 109/L);
• 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;
• 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;
• Patients who are allergic to contrast agents;

Sponsors & Collaborators

• Hangzhou Endonom Medtech Co., Ltd.: lead
• Wayne W.Zhang , Seattle，Washington，USA: collaborator

Study Sites (3)

Jia Hu

Chengdu, China

NOT YET RECRUITING

Weiguo Fu

Shanghai, China

RECRUITING

Honglin Dong

Taiyuan, China

RECRUITING

MeSH Terms

Conditions

Aortic Diseases; Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wayne W. Zhang

  Seattle，Washington，USA

  PRINCIPAL INVESTIGATOR

• Weiguo Fu

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wayne W. Zhang

CONTACT

wwzhang08@gmail.com

Weiguo Fu

CONTACT

13801760929; fu.weiguo@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 24, 2023
• Study Start: April 28, 2023
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: January 2, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)