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

NCT06520774 | Recruiting

• 1 other identifier: P134-01
• Study Type: interventional
• Target: 103
• Locations: 2 countries
• Sites: 17

Brief Summary

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

Conditions

Aortic Arch Aneurysm; Penetrating Aortic Ulcer

Keywords

Lifetech; Concave Supra-arch Branched Stent-Graft System; Endovascular Treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Immediate technical success rate

  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.

  6 and 12 months postoperatively

• Incidence rate of Type I/III endoleak at Intraoperative, pre-discharge, 6 and 12 months postoperatively

  Intraoperative, pre-discharge（up to 14 days）, 6 and 12 months postoperatively

• Incidence rate of stent graft migration at 6 and 12 months postoperatively

  6 and 12 months postoperatively

• The patency rate of the branch vessel at 6 and 12 months postoperatively

  6 and 12 months postoperatively

Study Arms (1)

Concave Supra-arch Branched Stent-Graft System

EXPERIMENTAL

Endovascular treatment of patients with Aortic Arch Diseases using Concave Supra-arch Branched Stent-Graft System

Device: Concave Supra-arch Branched Stent-Graft System

Interventions

Concave Supra-arch Branched Stent-Graft System DEVICE

To evaluate the efficacy and safety of Concave Supra-arch Branched Stent-Graft System for endovascular treatment of Aortic Arch Diseases

Concave Supra-arch Branched Stent-Graft 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 who are aged 18 to 80 years inclusive；
• 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;
• Anatomical criteria, including:
• Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery);
• 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;
• 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;
• 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;
• Have a suitable iliac, femoral, and superior arch arterial access;
• 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.;
• 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.

You may not qualify if:

• Patients either with ruptured or infected aneurysms;
• Patients with aortic dissection;
• Patients with general or local infections that may increase the risk of endovascular graft infection;
• 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;
• Previous endovascular intervention involving the aortic arch;
• Underwent open or endovascular surgery for abdominal aorta within the past 3 months;
• Patients with a history of stroke within the past 3 months (excluding TIA);
• Patients with aneurysms involving the distal descending aorta and requiring reconstruction of important visceral branch vessels within the abdomen;
• Patients with a history of myocardial infarction within the past 3 months;
• Patients with congestive heart failure - NYHA Class IV;
• Patients allergic to contrast agents, stent and delivery system materials (such as nitinol, polyester, PTFE, nylon polymer materials);
• Patients with contraindications to anticoagulant or antiplatelet drugs;
• Patients unable to tolerate general anesthesia;
• 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);
• Patients with connective tissue diseases, such as Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease;

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead
• Second Xiangya Hospital of Central South University: collaborator

Study Sites (17)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Second Xiangya Hospital of Central South University

Changsha, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, China

RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

RECRUITING

Union Hospital Affiliated to Fujian Medical University

Fuzhou, China

RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hanzhou, China

RECRUITING

The First Affiliated Hospital of Kunming Medical University

Kunming, China

RECRUITING

The First People's Hospital of Yunnan Province

Kunming, China

RECRUITING

Yunnan Fuwai Cardiovascular Disease Hospital

Kunming, China

RECRUITING

Jiangsu Provincial People's Hospital

Nanjing, China

RECRUITING

Nanjing First Hospital

Nanjing, China

RECRUITING

Zhongshan Hospital of Fudan University

Shanghai, China

RECRUITING

Shenzhen Hospital of Fuwai Hospital of Chinese Academy of Medical Sciences

Shenzhen, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, China

RECRUITING

Cardiovascular Disease Hospital Affiliated to Xiamen University

Xiamen, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Freiburg im Breisgau, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Aneurysm, Aortic Arch; Penetrating Atherosclerotic Ulcer

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Acute Aortic Syndrome; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• chang shu, Professor

  Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

chang shu, Professor

CONTACT

13607444222; changshu01@yahoo.com

Martin Czerny, Professor

CONTACT

martin.czerny@universitaets-herzzentrum.de

Study Design

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

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 25, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): June 30, 2031
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (16); DE (1)