Guo's Visceral Arteries Reconstruction: First in Man Study

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04731636

Collaborator

(none)

Enrollment

Location

Arm

33.3

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic aneurysms.

Condition or Disease	Intervention/Treatment	Phase
Thoracoabdominal Aortic Aneurysms	Device: G-Branch thoracoabdominal aortic stent system	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 20, 2019

Anticipated Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The incidence of Major Adverse events (MAE) within 30 days postoperative [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients aged greater than 18 years old and less than 85 years old;
Patients diagnosed with Crawford type I-V Thoracoabdominal Aortic Aneurysms and should meet at least one of the following conditions:
The maximum diameter of Thoracoabdominal Aortic Aneurysms >50mm;
The diameter increased by more than 5mm in the last 6 months;
The maximum diameter of Thoracoabdominal Aortic Aneurysms >45mm, with clear abdominal pain, low back pain and other symptoms;
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;
The range of the proximal aneurysm neck diameter of the thoracoabdominal aortic aneurysm is between 17mm to 42mm;
The length of the proximal aneurysm neck of the thoracoabdominal aortic aneurysm≥25mm;
The range of the distal anchoring area diameter of the thoracoabdominal aortic aneurysm is between 12mm to 25mm;
The length of the distal anchoring area of the thoracoabdominal aortic aneurysm ≥15mm;
The range of the anchoring area diameter of the important branches of abdominal viscera is between 4mm to 13mm;
The length of the anchoring area of the important branches of abdominal viscera≥15mm;
Patients who need to use a abdominal aortic bifurcation stent system should also meet the following conditions:
The range of the diameter of the iliac artery anchoring area is between 8mm to 26mm;
The length of the iliac artery anchoring area≥15mm;
The patients had suitable iliac, femoral, brachial and axillary artery approaches;
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:

Patients with rupture of the thoracoabdominal aortic aneurysm;
Patients with thoracoabdominal aortic dissection;
Patients with mycotic or infectious thoracoabdominal aortic aneurysms;
Patients who need to reconstruct bilateral internal iliac arteries;
Patients with severe stenosis, calcification, or mural thrombus in the anchoring area of the stent and easily lead to incomplete stent apposition;
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;
Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months;
Patients with a history of allergy to contrast media, stents and conveyor materials (including nickel and titanium, polyester, PTFE, and nylon polymer materials);
A patient with connective tissue diseases such as Marfan syndrome, Eaton syndrome, or Bessel's disease;
Patients with arteritis;
Patients with major organ failure or other serious diseases;
Patients who were not suitable for endovascular treatment, judged by the investigator;
Pregnant or lactating women or women who plan to get pregnant.
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;
Life expectancy is less than 12 months.