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

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

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Dissection
• Intervention / Treatment: Device: the Aorta Arch Stent Graft System combined with the Endovascular Needle System

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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chang Shu, Professor; Phone Number: 86 13910086222; Email: changshu@vip.126.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • Recruiting
      • Xiangya Second Hospital, Central South University
      • Contact: Chang Shu, Professor; Phone Number: 86 13910086222; Email: changshu@vip.126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria (to be selected if all of the following criteria are met)：

• 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 (If one of the following criteria is met, it will not be selected)：

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: 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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
• Investigators: Principal Investigator: Chang Shu, Professor, Xiangya Second Hospital, Central South University

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2021
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: aortic dissection; in situ fenestration; aortic dissection involving the aortic arch
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Dissection
• Other Study ID Numbers: LTP86-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No