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

NCT05126446 | Active Not Recruiting

• 1 other identifier: LTP86-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Aortic Dissection

Keywords

in situ fenestration; aortic dissection; aortic dissection involving the aortic arch

Outcome Measures

Primary Outcomes (3)

• Primary safety end point of the Aorta Arch Stent Graft System: no Major Adverse events（MAE） occurrence within 30 days after surgery

  MAE was defined as death related to aortic dissection, ischemic stroke, and paraplegia within 30 days after surgery

  Within 30 days after procedure

• Primary efficacy endpoint of the Aorta Arch Stent Graft System: treatment success at 12 months after surgery

  On the basis of successful surgery, the main and branch stents were unobstructed 12 months after surgery, with no internal leakage requiring intervention, no stent displacement (displacement ≤10mm), no new device-related rupture, and no device-induced aortic arch re-operation

  12 months after procedure

• Primary endpoint of the Endovascular Needle System: Immediate surgical success rate of the Endovascular Needle System

  Intraoperative DSA, the membrane was successfully broken in situ with the membrane rupture system, and the membrane rupture system was successfully withdrawn

  intraoperative

Study Arms (1)

aortic dissection involving the aortic arch

EXPERIMENTAL

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

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

Interventions

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

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

aortic dissection involving the aortic arch

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Xiangya Second Hospital, Central South University

Changsha, Hunan, 410011, China

Location

Related Publications (1)

• 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.

  PMID: 40289333 DERIVED

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

  Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 19, 2021
• Study Start: July 25, 2021
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

CN (1)