Percutaneous Endovascular Arch Repair Trial (PEART) Study

December 25, 2023 updated by: Hangzhou Endonom Medtech Co., Ltd.

Feasible Study on a New Technique of ZIPPER Aortic Arch Stentgraft System in the Treatment of Aortic Arch Disease

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ZIPPER aortic arch stentgraft system
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Freedom from major device/procedure-related adverse events within 30 days post-operation.
Time Frame: 30 days after intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of severe adverse events.
Time Frame: within 12 months post-intervention
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
within 12 months post-intervention
Immediate postoperative technical success.
Time Frame: immediately after intervention
Immediate technical success is defined as successful delivery of the aortic and branching stent graft conveyors to their predetermined positions, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body, absence of Type I and III endoleaks on angiography at the end of the procedure , and patent branch stents.
immediately after intervention
Incidence of Type I or Type III endoleaks.
Time Frame: 1 month, 6 months and 12 months post-intervention
Endoleak evaluated by DSA or CTA during operation and at 1 month, 6 months and 12 months after operation. Intraoperative endoleaks that were treated with adjuvant therapy were not documented. Endoleaks occurring in the same subject after completion of the procedure, and that were not treated at different visits, are counted as once.
1 month, 6 months and 12 months post-intervention
Incidence of aortic arch stent graft migration.
Time Frame: 1 month, 6 months and 12 months post-intervention
CTA will be performed at 1, 6, and 12 months after operation to determine if the stent has migrated, and evaluations will be recorded for both the main and branch stents. Migration is defined as the main and branched stents migrate more than 10 mm at postoperative follow-up compared with that 1 month post-intervention.
1 month, 6 months and 12 months post-intervention
Postoperative branch vessel patency rate.
Time Frame: 1 month, 6 months and 12 months post-intervention
CTA examinations will be performed at 1, 6, and 12 months post-operation to evaluate branch vessel revascularization and whether there is occlusion, stenosis, or stent thrombosis.
1 month, 6 months and 12 months post-intervention
Results of aortic remodeling after aortic dissection surgery
Time Frame: 1 month, 6 months and 12 months post-intervention
CTA examinations will be performed at 1, 6, and 12 months post-operation to evaluate results of aortic remodeling, including the expansion of the true lumen and the thrombosis of the false lumen at the coverage of the aortic dissection vascular stent to determine whether the blood vessel is successfully remodeled.
1 month, 6 months and 12 months post-intervention
Incidence of surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention.
Time Frame: within 12 months post-intervention
Whether or not the patient experienced surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention will be determined.
within 12 months post-intervention
Aortic-related mortality at 12 months post operation.
Time Frame: within 12 months post-intervention
Refers to death caused by aortic rupture or endovascular treatment.
within 12 months post-intervention
All-cause mortality and major stroke within 12 months post-procedure.
Time Frame: within 12 months post-intervention
All-cause mortality includes cardiac death, non-cardiac death, and unexpected death. Major stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days after stroke onset.
within 12 months post-intervention
Incidence of device-related adverse events.
Time Frame: within 12 months post-intervention
Device-related adverse event refers to an adverse medical event related to the use of test device during the clinical trial. However, a distinction should be made with respect to normal postoperative stress response, such as fever and chest and back discomfort, which, in the judgment of the investigator, need not be recorded as an adverse event.
within 12 months post-intervention
Progression control of aortic aneurysm
Time Frame: 1 month, 6 months and 12 months post-intervention
CTA examinations will be performed at 1, 6, and 12 months post-operation to evaluate results of progression control of aortic aneurysm. The maximum diameter of aortic aneurysm increases by ≤ 5 mm after 12 months of CTA examination compared with that before surgery.
1 month, 6 months and 12 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hangzhou Endonom Medtech Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wayne W.Zhang , Seattle，Washington，USA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Weiguo Fu, Fudan University
  • Principal Investigator: Wayne W. Zhang, Seattle，Washington，USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZIPPER V1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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