Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases

A Prospective, Multicenter, Single-Group Target-Value Clinical Trial: Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases

The objective of the study is to evaluate the safety and efficacy of the Lifetech Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases

Study Overview

• Status: Recruiting
• Conditions: Penetrating Aortic Ulcer; Aortic Arch Aneurysm
• Intervention / Treatment: Device: Concave Supra-arch Branched Stent-Graft System

Detailed Description

The physician must strictly adhere to the clinical study protocol and shall not deviate from or substantially alter it. However, in cases of emergency where there is an immediate risk to the subjects that must be eliminated immediately, a report may be submitted in written form afterward. During the study, any amendments to the clinical study protocol, informed consent documents, requests for deviation, and the resumption of a suspended clinical study must receive written approval from the Ethics Committee.

• Study Type: Interventional
• Enrollment (Estimated): 103
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: chang shu, Professor; Phone Number: 13607444222; Email: changshu01@yahoo.com
• Study Contact Backup: Name: Martin Czerny, Professor; Email: martin.czerny@universitaets-herzzentrum.de

Study Locations

• China
  • Changsha, China
    • Recruiting
    • Second Xiangya Hospital of Central South University
    • Contact: Chang Shu, Professor
  • Chengdu, China
    • Recruiting
    • West China Hospital, Sichuan University
    • Contact: Jia Hu, Professor
  • Fuzhou, China
    • Recruiting
    • The First Affiliated Hospital of Fujian Medical University
    • Contact: Fanggang Cai, Professor
  • Fuzhou, China
    • Recruiting
    • Union Hospital Affiliated to Fujian Medical University
    • Contact: Liangwan Chen, Professor
  • Hanzhou, China
    • Recruiting
    • The First Affiliated Hospital of Zhejiang University School of Medicine
    • Contact: Hongkun Zhang, Professor
  • Kunming, China
    • Recruiting
    • The First People's Hospital of Yunnan Province
    • Contact: Kunmei Gong, Professor
  • Kunming, China
    • Recruiting
    • The First Affiliated Hospital of Kunming Medical University
    • Contact: Bin Yang, Professor
  • Kunming, China
    • Recruiting
    • Yunnan Fuwai Cardiovascular Disease Hospital
    • Contact: Yuanyuan Guo, Professor
  • Nanjing, China
    • Recruiting
    • Jiangsu Provincial People's Hospital
    • Contact: Xiwei Zhang, Professor
  • Nanjing, China
    • Recruiting
    • Nanjing First Hospital
    • Contact: Xin Chen, Professor
  • Peking, China
    • Recruiting
    • Fuwai Hospital, Chinese Academy of Medical Sciences
    • Contact: Chang Shu, Professor
  • Shanghai, China
    • Recruiting
    • Zhongshan Hospital of Fudan University
    • Contact: Weiguo Fu, Professor
  • Shenzhen, China
    • Recruiting
    • Shenzhen Hospital of Fuwai Hospital of Chinese Academy of Medical Sciences
    • Contact: Chang Shu, Professor
  • Wuhan, China
    • Recruiting
    • Renmin Hospital of Wuhan University
    • Contact: Jun Xia, Professor
  • Xiamen, China
    • Recruiting
    • Cardiovascular Disease Hospital Affiliated to Xiamen University
    • Contact: Hui Zhuang, Professor
  • Zhengzhou, China
    • Recruiting
    • The First Affiliated Hospital of Zhengzhou University
    • Contact: Zhen Li, Professor
• Germany
  • Freiburg, Germany
    • Not yet recruiting
    • Universitäts-Herzzentrum Freiburg - Bad Krozingen
    • Contact: Martin Czerny, Professor; Email: martin.czerny@uniklinik-freiburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients who are aged 18 to 80 years inclusive；
2. Patients diagnosed with aortic arch aneurysms or penetrating ulcers that require intervention, and for whom the proximal end of the stent needs to be anchored in the Z0 zone;

3. Anatomical criteria, including:

   1. Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery);
   2. The diameter range of the anchoring area at the proximal end of the main body is between 25-45 mm and the length is greater than or equal to 30 mm;
   3. The diameter of the anchored area of supra-arch branch vessels (innominate artery, left common carotid artery, left subclavian artery) is between 5-18 mm, distal anchorage length is greater than or equal to 15 mm;
   4. Distance between the anterior edge of the innominate artery to the posterior edge of the left subclavian artery is less than or equal to 80 mm;
   5. Have a suitable iliac, femoral, and superior arch arterial access;
4. At least two researchers should assess that the subject is a high-risk patient for surgical treatment or has significant contraindications to surgery. It is recommended to refer to the following criteria: a score of ≥6 in the European System for Cardiac Operative Risk Evaluation (EuroSCORE) scoring system.;
5. Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up visits as required by the protocol.

Exclusion Criteria:

1. Patients either with ruptured or infected aneurysms;
2. Patients with aortic dissection;
3. Patients with general or local infections that may increase the risk of endovascular graft infection;
4. Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area, which is likely to impede stent-graft adherence or affect stent patency;
5. Previous endovascular intervention involving the aortic arch;
6. Underwent open or endovascular surgery for abdominal aorta within the past 3 months;
7. Patients with a history of stroke within the past 3 months (excluding TIA);
8. Patients with aneurysms involving the distal descending aorta and requiring reconstruction of important visceral branch vessels within the abdomen;
9. Patients with a history of myocardial infarction within the past 3 months;
10. Patients with congestive heart failure - NYHA Class IV;
11. Patients allergic to contrast agents, stent and delivery system materials (such as nitinol, polyester, PTFE, nylon polymer materials);
12. Patients with contraindications to anticoagulant or antiplatelet drugs;
13. Patients unable to tolerate general anesthesia;
14. Patients with abnormal liver and kidney function before surgery (ALT or AST more than 5 times the upper limit of normal; serum creatinine (Cr) >150umol/L);
15. Patients with connective tissue diseases, such as Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease;
16. Patients with arteritis;
17. Patients with a life expectancy of less than 1 year;
18. Women who are planning to conceive, pregnant or breastfeeding;
19. Patients deemed by the investigator as unsuitable for endovascular treatment;
20. Patients who have participated in other clinical studies and have not withdrawn or been excluded within the 3 months prior to the screening period of this study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Concave Supra-arch Branched Stent-Graft System; Endovascular treatment of patients with Aortic Arch Diseases using Concave Supra-arch Branched Stent-Graft System	Device: Concave Supra-arch Branched Stent-Graft System; To evaluate the efficacy and safety of Concave Supra-arch Branched Stent-Graft System for endovascular treatment of Aortic Arch Diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of composite endpoints	Composite endpoints refer to the occurrence of any of the following within 30 days post-surgery: all-cause mortality, disabling stroke, or permanent paraplegia.	within 30 days post-surgery
The clinical treatment success rate within 12 months	The 12-month clinical treatment success rate is a composite endpoint that includes immediate technical success after surgery and the absence of the following conditions at 12 months postoperatively: death, displacement of the aortic or branch covered stents on CTA follow-up, Type I or III endoleak, branch stent occlusion, and the need for secondary surgical intervention during the follow-up period.	pre-discharge (up to 14 days) and 12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of Type I/III endoleak at Intraoperative, pre-discharge, 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. A Type III endoleak results from a defect or misalignment between the components of the endograft. Similar to a Type I endoleak, a Type III endoleak causes systemic pressure within the aneurysm sac, increasing the risk of rupture. Consequently, Type III endoleaks also necessitate urgent attention. The definition of "pre-discharge" is either the discharge date or the 14th postoperative day, whichever occurs first.	Intraoperative, pre-discharge（up to 14 days）, 6 and 12 months postoperatively
Incidence rate of stent graft migration at 6 and 12 months postoperatively	Migration is defined according to reporting standards as a stent graft shift of more than 10 mm relative to a primary anatomic landmark, or any displacement that results in symptoms or necessitates therapy. A standardized measurement protocol was employed in accordance with the reporting guidelines.	6 and 12 months postoperatively
The patency rate of the branch vessel at 6 and 12 months postoperatively	Branch vessel patency is defined as stenosis of ≤50%	6 and 12 months postoperatively
Incidence rate of secondary surgical interventions related to the aortic arch and its branch arteries before discharge , at the 6 months and 12 months , and at 2-5 years postoperatively	Incidence of secondary surgical interventions related to the aortic arch and its branch arteries	before discharge （up to 14 days）, at the 6 months and 12 months , and at 2-5 years postoperative
Incidence rate of aneurysm rupture at Intraoperative, pre-discharge, 6 and 12 months, 2-5 years postoperatively	An aneurysm is an abnormal bulge or ballooning in the wall of a blood vessel. If an aneurysm ruptures, it causes internal bleeding, which can often be fatal.	Intraoperative, pre-discharge (up to 14 days）, 6 and 12 months 2-5 years postoperatively
All-cause mortality at 6 months, 12 months, and 2-5 years postoperatively	All-cause mortality refers to the rate of death from any cause within a specific population over a defined period of time.	6 months, 12 months, and 2-5 years postoperatively
Aortic-related mortality at 6 months, 12 months, and 2-5 years postoperatively	Aortic-related mortality refers to the proportion of deaths attributed to aortic conditions within a specific population over a defined period of time.	6 months, 12 months, and 2-5 years postoperatively
Incidence rate of severe adverse events at 6 months, 12 months, and 2-5 years postoperatively	A serious adverse event (SAE) in a clinical trial refers to any incident that results in death or a significant deterioration in health. This includes life-threatening illnesses or injuries, permanent impairment of a body structure or function, hospitalization or extended hospital stay, and medical or surgical interventions necessary to prevent permanent damage to physical structure or function. Additionally, SAEs encompass events causing fetal distress, fetal death, or congenital anomalies or defects.	6 months, 12 months, and 2-5 years postoperatively
Incidence rate of Device-related adverse events at 6 months, 12 months, and 2-5 years postoperatively	Medical device adverse events are unexpected incidents that occur during or after the use of a medical device by a patient. The World Health Organization (WHO) defines an adverse event as "a problem that can or does result in permanent impairment, injury, or death to the patient or the user." This definition implies two key requirements for determining a medical device adverse event. First, the event must be related to the usage of the medical device. Second, it must be assessed whether the use of the medical device could cause direct harm or potential harm.	6 months, 12 months, and 2-5 years postoperatively
Immediate technical success rate	Immediate technical success refers to the successful delivery of the delivery system to the predetermined position, successful deployment of the system, safe removal of the delivery system from the body, and absence of type I and III endoleaks that require intervention on angiography at the end of the procedure, with all branch stents being patent.	Immediate intraoperative
Incidence of increase in the maximum diameter of the aneurysm/depth of ulceration by more than 5 mm at 6 months and 12 months postoperatively.	Increase in the maximum diameter of the aneurysm/depth of ulceration> 5 mm	6 and 12 months postoperatively
Incidence rate of delivery system-related complications during perioperative period (from surgery to 30 days after surgery)	The incidence rate of related complications during the perioperative period (from surgery to 30 days post-surgery) includes intraoperative conversion surgeries due to delivery devices, as well as bleeding, hematoma, and pseudoaneurysm occurring along the delivery access route.	perioperative period (from surgery to 30 days after surgery)
Incidence rate of MAE at Intraoperative, pre-discharge and within 30 days postoperatively	A Major Adverse Event (MAE) is defined as any occurrence of all-cause mortality, intestinal necrosis, kidney failure, stroke (excluding TIA), permanent paraplegia, myocardial infarction, or respiratory failure.	Intraoperative, pre-discharge（up to 14 days） and within 30 days postoperatively

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
• Collaborators: Second Xiangya Hospital of Central South University
• Investigators: Principal Investigator: chang shu, Professor, Second Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: July 7, 2024
• First Submitted That Met QC Criteria: July 20, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Endovascular Treatment; Lifetech; Concave Supra-arch Branched Stent-Graft System
• Additional Relevant MeSH Terms: Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Penetrating Atherosclerotic Ulcer; Aneurysm, Aortic Arch
• Other Study ID Numbers: P134-01

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
• product manufactured in and exported from the U.S.: No