Study on the Aortic Arch Single Branch Stent Graft System

June 10, 2025 updated by: Lifetech Scientific (Shenzhen) Co., Ltd.

Study on the Safety and Efficacy of the Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

The objective of the study is to evaluate the Safety and Efficacy of Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

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 physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee

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.
135

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 Locations

  • China
      • Changsha, China
        • Recruiting
        • Second Xiangya Hospital of Central South University
        • Contact:
          • Chang Shu, Professor

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:

  • Age between 18 and 80 years, gender unrestricted.
  • Patients are diagnosed with Stanford Type B aortic dissection and need revascularization of the left subclavian artery.

  • Anatomical criteria:

    • The diameter range of the proximal aortic landing zone is 20-42 mm.
    • The length of the proximal aortic landing zone (the distance from the posterior edge of the left common carotid artery orifice to the first intimal tear) is ≥15 mm.
    • The distance between the left common carotid artery and the left subclavian artery is ≥5 mm.
    • The length of the left subclavian artery landing zone is ≥25 mm, and the diameter range of the landing zone is 5-15 mm.
    • Suitable access to the femoral artery, iliac artery, and upper limb artery.
  • Patients understand the purpose of the study, volunteer to participate, and are willing to complete follow - up visits as required by the protocol.

Exclusion Criteria:

  • Previously undergone endovascular interventional treatment involving the aortic arch, or having a history of aortic surgical repair surgery, which affects the implantation and evaluation of the single branched covered stent system of the aortic arch.
  • Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area pose challenges. Such conditions may easily prevent covered stents from adhering to the vessel wall or affect stent patency.
  • Infectious aortic diseases, giant cell arteritis, Marfan syndrome (or other hereditary connective tissue diseases).
  • Patients with systemic or local infections that may increase the risk of infection of the endovascular graft.
  • Patients who have received abdominal aortic surgical or endovascular interventional surgery within the past 3 months.
  • Patients who have had a stroke attack (excluding transient ischemic attack, TIA) or myocardial infarction within the past 3 months.
  • Patients known to be allergic to contrast agents, stent materials, and delivery device materials (referring to nitinol, Dacron, PTFE, nylon polymer materials).
  • Patients known to have contraindications to anticoagulant and antiplatelet drugs.
  • Patients intolerant to general anesthesia.
  • Patients with severe abnormalities in liver, kidney, and cardiac function before the operation [Subjects with a serum creatinine level exceeding 150 μmol/L; Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 5 times the upper limit of the normal value; Subjects with serum total bilirubin (STB) exceeding 2 times the upper limit of the normal value; Subjects with a left ventricular ejection fraction lower than 50% as indicated by echocardiography.].
  • Patients whose expected lifespan is shorter than 1 year.
  • Female patients who are planning to conceive, are currently pregnant, or are breastfeeding.
  • Patients whom, in the researcher's judgment, are not appropriate candidates for endovascular treatment.
  • Patients who have been involved in other clinical studies and have not withdrawn from or exited the respective study groups within the three months preceding the screening period of this present study.

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: Other
  • 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: Aortic Arch Single Branch Covered Stent System
Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch
Device: Aortic Arch Single Branch Covered Stent System
to Evaluate the Safety and Efficacy of the Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

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
Incidence rate for freedom from major adverse events (MAE) within 30 days postoperatively
Time Frame: pre-discharge up to 14 days and 30 days post-surgery
Major adverse events refer to the occurrences of all-cause death, myocardial infarction, renal failure, liver failure, respiratory failure, paraplegia, ischemic stroke, intestinal necrosis. Among them, renal failure means that it leads to persistent dialysis, kidney transplantation, or other fatal outcomes. Respiratory failure means that it leads to a significantly prolonged intubation time, tracheotomy, deterioration of lung function, or other fatal outcomes. Intestinal necrosis refers to intestinal ischemia that requires intestinal resection or leads to other fatal outcomes.
pre-discharge up to 14 days and 30 days post-surgery
Procedural success rate of aortic dissection treatment 12 months postoperatively
Time Frame: intraoperative and 12 months postoperatively
The composite endpoints include immediate technical success post-procedure and, at the 12-month CTA reexamination, the absence of displacement of the main aortic and branch stents, no type I or III endoleaks, patency of the branch stents, and no secondary surgical interventions during follow-up.
intraoperative and 12 months postoperatively

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
All-cause mortality
Time Frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
All-cause mortality Refers to deaths from any cause that occur within the follow-up time points.
Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Mortality rate related to aortic dissection
Time Frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Mortality rate related to aortic dissection refers to the death caused by the rupture of aortic dissection or the endovascular treatment of aortic dissection.
Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Incidence rate of severe adverse events
Time Frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Serious adverse events refer to those occurring during the process of a clinical trial that lead to death or a serious deterioration of the health condition. This includes fatal diseases or injuries, permanent defects in body structures or body functions, the need for hospitalization or an extended hospital stay, and the requirement for medical or surgical interventions to prevent permanent defects in body structures or body functions.
Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Incidence rate of Device-related adverse events
Time Frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Adverse events refer to adverse medical events that occur during the process of a clinical trial, regardless of whether they are related to the medical device used in the trial. However, normal postoperative stress responses should be distinguished, such as fever, discomfort in the chest and back, etc. If, upon the judgment of the researcher, it is determined to be a normal postoperative stress response, there is no need to record it as an adverse event of the medical device. Adverse events related to the medical device refer to situations that are determined by the researcher to be definitely related, possibly related, or undeterminable in relation to the medical device used in the trial.
Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
The incidence rate of left upper limb ischemia
Time Frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Left upper limb ischemia may present with weakness, coldness, pain, and numbness in the left upper limb. The ulnar artery, radial artery, and brachial artery may show weakened or absent pulsation.
Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Incidence rate of Type I/III endoleak
Time Frame: Intraoperative, pre-discharge（up to 14 days）, within 30 days and 6 and 12 months postoperatively
A Type I endoleak occurs when there is a gap between the graft and the vessel wall at the "seal zones." This gap allows blood to flow alongside the graft into the aneurysm sac, creating pressure within the sac and increasing the risk of rupture. Type I endoleaks often occur when the aneurysm's anatomy is unsuitable for endovascular aneurysm repair (EVAR) or due to inappropriate device selection. However, vessel dilation over time can also cause this type of endoleak. Immediate attention is typically required because of the high risk of sac enlargement and rupture.
Intraoperative, pre-discharge（up to 14 days）, within 30 days and 6 and 12 months postoperatively
Incidence rate of stent graft migration
Time Frame: 6 and 12 months postoperatively
Migration is defined as the single branched covered stent system of the aortic arch having a displacement of more than 10 mm compared with its position before discharge .
6 and 12 months postoperatively
The patency rate of the branch vessel
Time Frame: Pre-discharge up to 14 days, 6 and 12 months postoperatively
Branch vessel patency is defined as stenosis of ≤50%
Pre-discharge up to 14 days, 6 and 12 months postoperatively
The success rate of vascular remodeling for aortic dissection
Time Frame: within 30 days and 6 and 12 months postoperatively
Evaluate the expansion of the true lumen and the thrombosis of the false lumen at the sites covered by the vascular stents for aortic dissection, so as to determine whether the vascular remodeling is successful.
within 30 days and 6 and 12 months postoperatively
The incidence rate of conversion to thoracotomy or secondary interventional surgery due to aortic dissection
Time Frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Evaluate whether the subjects have been converted to thoracotomy or secondary interventional surgery due to aortic dissection.
Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively

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.
Lifetech Scientific (Shenzhen) Co., Ltd.

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: chang shu, Professor, Chinese Academy of Medical Sciences, Fuwai Hospital

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 30, 2025

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 30, 2027

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.
June 30, 2031

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).
March 31, 2025

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.
March 31, 2025

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.
April 8, 2025

Study Record Updates

Last Update Posted (Actual)

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.
June 11, 2025

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.
June 10, 2025

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.
March 1, 2025

More Information

Terms related to this study

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.
  • P158CT(CN)-01

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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