Study on the Aortic Arch Single Branch Stent Graft System

NCT06915545 | Recruiting

• 1 other identifier: P158CT(CN)-01
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aortic Dissection

Outcome Measures

Primary Outcomes (2)

• Incidence rate for freedom from major adverse events (MAE) within 30 days postoperatively

  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

  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 Outcomes (10)

• All-cause mortality

  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

  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

  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

  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

  Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively

Study Arms (1)

Aortic Arch Single Branch Covered Stent System

EXPERIMENTAL

Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

Device: Aortic Arch Single Branch Covered Stent System

Interventions

Aortic Arch Single Branch Covered Stent System DEVICE

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

Aortic Arch Single Branch Covered Stent 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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (1)

Second Xiangya Hospital of Central South University

Changsha, China

RECRUITING

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• chang shu, Professor

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

chang shu, Professor

CONTACT

13607444222; changshu01@yahoo.com

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: March 31, 2025
• First Posted: April 8, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2031
• Last Updated: June 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)