Guo's Visceral Arteries Reconstruction: First in Man Study

Guo's Visceral Arteries Reconstruction :The First in Man Study of G-Branch Multiple Branch Stent Graft System.

A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysm.

Study Overview

• Status: Completed
• Conditions: Thoracoabdominal Aortic Aneurysm; Pararenal Aortic Aneurysm
• Intervention / Treatment: Device: Thoracoabdominal aortic stent system

Detailed Description

The study is mainly for patients with Crawford type I-V thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysm, and all subjects who passed the screening and signed the informed consent will be enrolled. Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent system.

Patients will be followed up at discharge, 1 month, 6 months, 12 months after the implantation.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age ≥18 and ≤80 years;

2. Patients diagnosed with type Crawford I-V thoracoabdominal aortic aneurysmsa and pararenal abdominal aortic aneurysm, and should meet at least one of the following conditions:

   1. The maximum diameter of thoracoabdominal aortic aneurysms and pararenal abdorminal aortic aneurysm > 50 mm;
   2. Rapid growth of sac >5 mm in diameter in the most recent 6 months;
   3. Definite symptoms of abdominal pain and low back pain associated with thoracicabdominal aortic aneurysms.
3. Patients with four indispensable reno-visceral arteries including superior mesenteric artery, celiac trunk and bilaterial renal arteries.
4. Proximal landing zone 20-36 mm in diameter;
5. Proximal landing zone ≥25 mm in length;
6. If distal landing zone in abdominal aorta, distal landing zone should be 12-36mm in diameter and ≥15 mm in length.
7. The visceral vascular branches landing zone 6~13 mm in diameter and ≥15 mm in length;
8. The renal artery landing zone 4.5~9 mm in diameter and ≥15 mm in length;

9. Patients who using the abdominal aortic bifurcation stent graft system should also meet the following criteria:

   1. The ilac artery landing zone 7 ~25 mm in diameter;
   2. The ilac artery landing zone ≥15 mm in length;
10. Patients with appropriate iliacofemoral access and at least one patent upper extremity access;
11. Patients who can understand the purpose of the trial, volunntarily 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. Requiring simultaneous coverage or embolisation for bilateral internal iliac arteries;
5. Severe stenosis, calcification, or mural thrombus at stent-graft landing zone;
6. Diagnosis of acute coronary syndrome within 6 months;
7. Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months;
8. An allergic history for contrast agents, anticoagulants, antiplatelet drugs, stent graft or materials of delivery system；
9. Patients with connective tissue diseases;
10. Patients with takayasu arteritis;
11. Patients with serious vital organ dysfunction or other serious disease;
12. Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol/L;
13. Severe pulmonary insufficiency who cannot tolerate general anaesthesia;
14. Severe coagulation dysfunction;
15. Undergone major surgical or interventionic surgery within 30 days before surgery;
16. Patients whose systemic or local infection may increase the risk of intravascular graft infection;
17. Planning pregnancy, pregnancy, or breastfeeding;
18. 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 ;
19. Life expectancy less than 1 year;
20. Patients not appropriate for endovascular repair based on the investigators' clinical judgement.

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: G-Branch Thoracoabdominal Aortic Stent System; Patients with Crawford type I-V thoracoabdominal aortic aneurysms and Pararenal abdominal aortic aneurysm, and passed the screening and signed the Informed Consent Form	Device: Thoracoabdominal aortic stent system; Patients who meet all inclusion criteria and don't meet any exclusion criteria were implanted with thoracoabdominal aortic stent system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Major Adverse Events (MAE) Within 30 Days Postoperative	Major Adverse events (MAE) are defined as all-cause death, liver failure, intestinal necrosis, splenic infarction, renal infarction, renal failure, cerebral infarction, paraplegia, myocardial infarction, and respiratory failure.	within 30-days postoperative

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): October 17, 2019
• Primary Completion (Actual): March 10, 2022
• Study Completion (Actual): March 22, 2022

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 7, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Guo's Visceral Arteries Reconstruction; Thoracoabdominal aortic stent system; Thoracoabdominal Aortic Aneurysms; G-Branch; Pararenal abdominal aortic aneurysm
• 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: TAAA-FIM-001

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