Clinical trial NCT05126446: the Aorta Arch Stent Graft System Combined With the Endovascular Needle System in Situ Fenestration
Official title: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Dissection
Keywords: in situ fenestration
aortic dissection
aortic dissection involving the aortic arch
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Primary safety end point of the Aorta Arch Stent Graft System: no Major Adverse events（MAE） occurrence within 30 days after surgery
timeFrame: Within 30 days after procedure
measure: Primary efficacy endpoint of the Aorta Arch Stent Graft System: treatment success at 12 months after surgery
timeFrame: 12 months after procedure
measure: Primary endpoint of the Endovascular Needle System: Immediate surgical success rate of the Endovascular Needle System
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Second Hospital, Central South University
state: Hunan
Study officials:
affiliation: Xiangya Second Hospital, Central South University
name: Chang Shu, Professor
role: PRINCIPAL_INVESTIGATOR
References: