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 endovascular treatment of thoracoabdominal aortic aneurysms.

Study Overview

• Status: Unknown
• Conditions: Thoracoabdominal Aortic Aneurysms
• Intervention / Treatment: Device: G-Branch thoracoabdominal aortic stent system

Detailed Description

The study is mainly for patients with Crawford type I-V thoracoabdominal aortic aneurysms, 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 (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Patients aged greater than 18 years old and less than 85 years old;

2. Patients diagnosed with Crawford type I-V Thoracoabdominal Aortic Aneurysms and should meet at least one of the following conditions:

   1. The maximum diameter of Thoracoabdominal Aortic Aneurysms >50mm;
   2. The diameter increased by more than 5mm in the last 6 months;
   3. The maximum diameter of Thoracoabdominal Aortic Aneurysms >45mm, with clear abdominal pain, low back pain and other symptoms;
3. Patients with thoracoabdominal aortic aneurysms who need to reconstruct the important branches of abdominal viscera; The important branches of abdominal viscera include superior mesenteric artery, celiac trunk and left and right renal artery;
4. The range of the proximal aneurysm neck diameter of the thoracoabdominal aortic aneurysm is between 17mm to 42mm;
5. The length of the proximal aneurysm neck of the thoracoabdominal aortic aneurysm≥25mm;
6. The range of the distal anchoring area diameter of the thoracoabdominal aortic aneurysm is between 12mm to 25mm;
7. The length of the distal anchoring area of the thoracoabdominal aortic aneurysm ≥15mm;
8. The range of the anchoring area diameter of the important branches of abdominal viscera is between 4mm to 13mm;
9. The length of the anchoring area of the important branches of abdominal viscera≥15mm;

10. Patients who need to use a abdominal aortic bifurcation stent system should also meet the following conditions:

    1. The range of the diameter of the iliac artery anchoring area is between 8mm to 26mm;
    2. The length of the iliac artery anchoring area≥15mm;
11. The patients had suitable iliac, femoral, brachial and axillary artery approaches;
12. Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent, and are willing to complete the follow-up according to the requirements of the protocol.

Exclusion Criteria:

1. Patients with rupture of the thoracoabdominal aortic aneurysm;
2. Patients with thoracoabdominal aortic dissection;
3. Patients with mycotic or infectious thoracoabdominal aortic aneurysms;
4. Patients who need to reconstruct bilateral internal iliac arteries;
5. Patients with severe stenosis, calcification, or mural thrombus in the anchoring area of the stent and easily lead to incomplete stent apposition;
6. Patients with a history of myocardial infarction or unstable angina pectoris for 6 months. Characteristics of unstable angina pectoris: angina symptoms gradually increased, new onset of rest or night angina pectoris or occurrence of angina prolonged;
7. Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months;
8. Patients with a history of allergy to contrast media, stents and conveyor materials (including nickel and titanium, polyester, PTFE, and nylon polymer materials);
9. A patient with connective tissue diseases such as Marfan syndrome, Eaton syndrome, or Bessel's disease;
10. Patients with arteritis;
11. Patients with major organ failure or other serious diseases;
12. Patients who were not suitable for endovascular treatment, judged by the investigator;
13. Pregnant or lactating women or women who plan to get pregnant.
14. The patients participated in other clinical trials and did not come out of the group or withdraw within the first 3 months of the screening period of this trial;
15. Life expectancy is less than 12 months.

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: Intervention arm; Patients with Crawford type I-V thoracoabdominal aortic aneurysms, and passed the screening and signed the informed consent form.	Device: G-Branch thoracoabdominal aortic stent system; Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent system.

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 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): June 20, 2019
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): March 31, 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): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Guo's Visceral Arteries Reconstruction; Thoracoabdominal aortic stent system; Thoracoabdominal Aortic Aneurysms; G-Branch
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: TAAA-FIM-001

Drug and device information, study documents

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