the Aorta Arch Stent Graft System Combined With the Endovascular Needle System in Situ Fenestration

NCT ID: NCT05126446

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-25
• Study Completion Date: 2028-03-30

Brief Summary

A prospective, multi-center, single-group target value method to evaluate the safety and effectiveness of the Aorta Arch Stent Graft System combined with the Endovascular Needle System in situ fenestration technology in the treatment of aortic dissection involving the aortic arch

Detailed Description

1. Clinical trials using prospective, multi-center, single-group target value design;

2. 120 subjects with aortic dissection requiring partial arch reconstruction will be enrolled in more than 30 centers in China, and they will meet the test enrollment requirements.

3. CTA examination was performed at baseline, 30 days, 6 months, 12 months, 36 months, and 60 months after surgery to determine the pathological status and the status of postoperative aortic and branch revascularization

Conditions

Aortic Dissection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

aortic dissection involving the aortic arch

Aortic dissection involving the aortic arch was diagnosed in patients requiring revascularization of the aortic arch and its branches

Group Type: EXPERIMENTAL

the Aorta Arch Stent Graft System combined with the Endovascular Needle System

Intervention Type: DEVICE

Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with device

Interventions

the Aorta Arch Stent Graft System combined with the Endovascular Needle System

Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 years old ≤age≤80 years old, no gender limitation;
• Diagnosis of aortic dissection and reconstruction of the left subclavian artery;
• The main branches and branches of the aortic arch at the lesion site have sufficient anatomical basis:

• The diameter range of the near-end anchoring zone of the main body of the fixed mechanism: 21-46mm;
• The length of the anchor zone near the principal part of the tunnel is ≥10mm;
• The length of the anchor zone of the branching vessel of the convex target is ≥15mm;
• The diameter range of the distal anchoring zone of the target branching vessel is 5-18mm.
• The patient has adequate surgical access vessels;
• Patients who understand the purpose of the study, voluntarily participate in and sign informed consent, and are willing to follow up.

Exclusion Criteria

• The patient is pregnant or breastfeeding;
• The patient had a history of cardiac surgery (congenital heart disease surgery, heart valve surgery, coronary heart disease surgery, thoracic aortic surgery, etc.), which would affect the implementation of this TEVAR surgery;
• The patient has been implanted or planned to be implanted with left ventricular auxiliary pump, interventional valve and other instruments, or is planning to undergo coronary intervention surgery, and aortic dissection is expected to affect the function of such instruments or such instruments will affect the operation of aortic dissection;
• Patients with severe hematoma on the aortic wall in the proximal anchoring area of the stent;
• Marfan syndrome and other connective tissue diseases, arteritis;
• Patients with a history of allergy to contrast agents, anesthetics, antiplatelet drugs, anticoagulants, nickel peptide alloys, and polytetrafluoroethylene materials;
• Patients with a history of cerebral infarction or myocardial infarction within 3 months before surgery;
• Patients with active bleeding and coagulopathy;
• Abnormal renal function: patients with preoperative creatinine > 2.5 times the normal upper limit value;
• Abnormal liver function: patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the normal upper limit value, or patients with serum total bilirubin (STB) > 2 times the normal upper limit value;
• Patients with end-stage diseases with a life expectancy of less than one year;
• patients with poor compliance considered by the investigator;
• Patients participating in other clinical trials at the same time.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lifetech Scientific (Shenzhen) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chang Shu, Professor

Role: PRINCIPAL_INVESTIGATOR

Xiangya Second Hospital, Central South University

Locations

Xiangya Second Hospital, Central South University

Changsha, Hunan, China

Countries

China

References

Tan Y, Chen W, Li Z, Xu H, Zhao Y, Zhou D, Bai Y, Wang X, Xu T, Zhang Y, Xu J, Shu X. Early Results of a Single-Center Prospective Clinical Trial: In Situ Fenestration System for Aortic Dissection. Vasc Endovascular Surg. 2025 Aug;59(6):600-609. doi: 10.1177/15385744251330013. Epub 2025 Apr 27.

Reference Type: DERIVED

PMID: 40289333 (View on PubMed)

Other Identifiers

LTP86-01

Identifier Type: -

Identifier Source: org_study_id