Study on Multibranched Stent Graft System in the Treatment of Thoracoabdominal Aortic Aneurysm

GUo's Renovisceral Artery Reconstruction-2: a Prospective,Single Center,Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a multibRANched sTEnt Graft systEm for Thoracoabdominal Aortic Aneurysm

The objective of this study is to evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA)

Study Overview

• Status: Recruiting
• Conditions: Thoracoabdominal Aortic Aneurysm
• Intervention / Treatment: Device: multibranched stent graft system

Detailed Description

The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee

• Study Type: Interventional
• Enrollment (Estimated): 73
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Xu, PM; Phone Number: 86 15695219339; Email: xuwei@lifetechmed.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Chinese Pla General Hospital
    • Contact: Wei Guo, Professor
    • Principal Investigator: Wei Guo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 and ≤80 years;

2. Patients diagnosed with thoracoabdominal aortic aneurysm (based on the modified Crawford classification and the 2019 European guidelines for the treatment of aortic aneurysms), and should meet at least one of the following conditions:

   1. Maximum diameter of TAAA >50 mm,
   2. Rapid growth of sac >5 mm in diameter in the most recent 6 months, or rapid growth >10 mm in diameter within 1 year
   3. Symptoms related to thoracoabdominal aortic aneurysm, such as clear abdominal pain and back pain.

3. Anatomical criteria, including:

   1. Proximal landing zone 17-36 mm in diameter and ≥25 mm in length
   2. If distal landing zone in abdominal aorta:Distal landing zone 12-36 mm in diameter and ≥20 mm in length If distal landing zone in iliac artery:Distal landing zone 7-25 mm in diameter and ≥15 mm in length
   3. Visceral vessel landing zone 6-13 mm in diameter and ≥15 mm in length
   4. Renal artery landing zone 4.5-9 mm in diameter and ≥15 mm in length
4. Patients with Feasible iliofemoral artery and upper patent upper extremity access;
5. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to complete the follow-up according to the requirements of the protocol;

Exclusion Criteria:

1. Ruptured aortic aneurysm in unstable haemodynamic condition;
2. Aneurysmal aortic dissection;
3. Infected or mycotic aortic aneurysm;
4. Patients whose systemic or local infection may increase the risk of intravascular graft infection;
5. Patients with occlusion of the superior mesenteric artery, celiac trunk, or renal artery.
6. Requiring simultaneous coverage or embolisation for bilateral internal iliac arteries;
7. Severe stenosis, calcification, or mural thrombus at stent-graft landing zone;
8. Diagnosis of acute coronary syndrome within 6 months; Acute coronary syndrome refers to an acute cardiac ischemia syndrome caused by the rupture or erosion of unstable atherosclerotic plaques in the coronary arteries, which is followed by the formation of fresh thrombus. It includes ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris.
9. Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months;
10. Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol/L;
11. Severe pulmonary insufficiency who cannot tolerate general anaesthesia;
12. Severe coagulation dysfunction;
13. Undergone major surgical or interventionic surgery within 30 days before surgery;
14. An allergic history for contrast agents, anticoagulants, antiplatelet drugs, stent graft or materials of delivery system( (referring to nickel-titanium, polyester, PTFE, nylon-based polymer materials);
15. Patients with connective tissue diseases, such as systemic lupus erythematosus, Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease;
16. Patients with takayasu arteritis;
17. Patients with serious vital organ dysfunction or other serious disease;
18. Planning pregnancy, pregnancy, or breastfeeding;
19. The patient participated in other clinical trials or not completed or withdrawn from other clinical trials within the last 3 months at the time of screening period ;
20. Life expectancy less than 1 year;
21. Patients who are not appropriate for endovascular repair based on the investigators' clinical judgement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: multibranched stent graft system; Endovascular treatment of patients withThoracoabdominal Aortic Aneurysm using multibranched stent graft system	Device: multibranched stent graft system; To evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Incidence of Major Adverse Events (MAE) Within 30 Days Postoperative	Major Adverse Event (MAE) was defined as all-cause death, liver failure, intestinal necrosis, kidney failure, stroke, permanent paraplegia, myocardial infarction, and respiratory failure	within 30 days postoperative
The success rate of thoracic and abdominal aortic aneurysm treatment after 12 months of surgery	Successful treatment of thoracoabdominal aortic aneurysm is a composite endpoint that requires meeting the following indicators at the same time: immediate technical success (immediate technical success refers to the successful delivery of the delivery system to the predetermined position, successful deployment of the system, safe withdrawal of the delivery system from the body, and no type I/III endoleak), and no secondary surgical intervention related to thoracoabdominal aortic aneurysm within 12 months after surgery (secondary surgery caused by aneurysm rupture, continuous enlargement, stent migration, type I/III endoleak, branch vessel stenosis/occlusion).	Intraoperative and 12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delivery system-related complications during perioperative period (from surgery to 30 days after surgery)	The incidence rate of related complications during the perioperative period (from surgery to 30 days after surgery), including intraoperative transition surgeries caused by delivery devices, bleeding, hematoma, and pseudoaneurysm during the delivery access route.	perioperative period (from surgery to 30 days after surgery)
All-cause mortality at 6 months and 12 months postoperatively	All-cause mortality refers to death from any cause that occurs within the follow-up time period.	6 months and 12 months postoperatively
Mortality Rate Related to Thoracoabdominal Aortic Aneurysm at 6 months and 12 months postoperatively	Mortality related to thoracoabdominal aortic aneurysm refers to death caused by the rupture of the thoracoabdominal aortic aneurysm or surgery for the treatment of the thoracoabdominal aortic aneurysm.	6 months and 12 months postoperatively
Incidence of severe adverse events at 6 and 12 months postoperatively	A serious adverse event refers to any occurrence during a clinical trial that leads to death or a serious deterioration in health status, including fatal illnesses or injuries, permanent defects in physical structure or function, the need for hospitalization or prolongation of hospital stay, the need for medical or surgical intervention to prevent permanent defects in physical structure or function, or events leading to fetal distress, fetal death, or congenital abnormalities or defects.	6 months and 12 months postoperatively
Device-related adverse events at 6 months and 12 months postoperatively	Adverse events refers to an unfavorable medical event that occurs during a clinical trial, regardless of whether it is related to the medical device being tested. However, it should be distinguished from normal postoperative stress reactions, such as fever and constipation. If the researcher determines that they are normal postoperative stress reactions, they do not need to be recorded as adverse events. If the surgeon chooses staged reconstruction due to the subject's medical condition, it does not constitute an adverse event.	6 months and 12 months postoperatively
Incidence of secondary surgical interventions related to the Thoracoabdominal Aortic Aneurysm at 6 and 12 months postoperatively	Notes: Due to the patient's condition, the surgeon's choice of staged reconstruction does not constitute a secondary surgical intervention.	6 and 12 months postoperatively
Incidence rate of aneurysmal enlargement at 6 and 12 months postoperatively	aneurysmal enlargement defined as a maximum aortic diameter increase of > 5 mm	6 and 12 months postoperatively
Incidence rate of Type I/III endoleak at 6 and 12 months postoperatively	Type I endoleak, also known as peri-graft endoleak or graft-related endoleak, refers to the leakage caused by the inability of the stent graft to tightly adhere to the autologous vessel, leading to continuous blood flow into the aneurysm sac. This includes proximal and distal Type I endoleaks. Type III endoleak refers to the leakage caused by the inability of the stent graft's own connectors to tightly adhere or the rupture of the artificial vessel, which results in continuous blood flow into the aneurysm sac.	6 and 12 months postoperatively
Incidence rate of Stent graft migration at 6 and 12 months postoperatively	The evaluation criteria are: at the postoperative follow-up nodes, the position shift of the thoracoabdominal aortic covered stent is greater than 10mm compared to before discharge, or the shift causes symptoms or requires intervention.	6 and 12 months postoperatively
The patency rate of the renovisceral artery at 6 and 12 months postoperatively	branch vessel patency is defined as stenosis of ≤50%	6 and 12 months postoperatively

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
• Investigators: Principal Investigator: Wei Guo, Professor, Chinese Pla General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Endovascular Treatment; Lifetech; multibranched stent graft system
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aortic Aneurysm, Abdominal; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aortic Aneurysm, Thoracoabdominal
• Other Study ID Numbers: XJ-TAAA-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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