Guo's Visceral Arteries Reconstruction: First in Man Study

NCT04731636 | Completed Results

• 1 other identifier: TAAA-FIM-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thoracoabdominal Aortic Aneurysm; Pararenal Aortic Aneurysm

Keywords

Guo's Visceral Arteries Reconstruction; Thoracoabdominal aortic stent system; Thoracoabdominal Aortic Aneurysms; G-Branch; Pararenal abdominal aortic aneurysm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

G-Branch Thoracoabdominal Aortic Stent System

EXPERIMENTAL

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

Interventions

Thoracoabdominal aortic stent system DEVICE

Patients who meet all inclusion criteria and don't meet any exclusion criteria were implanted with thoracoabdominal aortic stent system.

G-Branch Thoracoabdominal Aortic Stent System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and ≤80 years;
• 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:
• The maximum diameter of thoracoabdominal aortic aneurysms and pararenal abdorminal aortic aneurysm \> 50 mm;
• Rapid growth of sac \>5 mm in diameter in the most recent 6 months;
• Definite symptoms of abdominal pain and low back pain associated with thoracicabdominal aortic aneurysms.
• Patients with four indispensable reno-visceral arteries including superior mesenteric artery, celiac trunk and bilaterial renal arteries.
• Proximal landing zone 20-36 mm in diameter;
• Proximal landing zone ≥25 mm in length;
• If distal landing zone in abdominal aorta, distal landing zone should be 12-36mm in diameter and ≥15 mm in length.
• The visceral vascular branches landing zone 6\~13 mm in diameter and ≥15 mm in length;
• The renal artery landing zone 4.5\~9 mm in diameter and ≥15 mm in length;
• Patients who using the abdominal aortic bifurcation stent graft system should also meet the following criteria:
• The ilac artery landing zone 7 \~25 mm in diameter;
• The ilac artery landing zone ≥15 mm in length;
• Patients with appropriate iliacofemoral access and at least one patent upper extremity access;

You may not qualify if:

• Ruptured aortic aneurysm in unstable haemodynamic condition;
• Aneurysmal aortic dissection;
• Infected or mycotic aortic aneurysm;
• Requiring simultaneous coverage or embolisation for bilateral internal iliac arteries;
• Severe stenosis, calcification, or mural thrombus at stent-graft landing zone;
• Diagnosis of acute coronary syndrome within 6 months;
• Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months;
• An allergic history for contrast agents, anticoagulants, antiplatelet drugs, stent graft or materials of delivery system；
• Patients with connective tissue diseases;
• Patients with takayasu arteritis;
• Patients with serious vital organ dysfunction or other serious disease;
• Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol/L;
• Severe pulmonary insufficiency who cannot tolerate general anaesthesia;
• Severe coagulation dysfunction;
• Undergone major surgical or interventionic surgery within 30 days before surgery;

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Clinical manager
• Organization: LifeTechScientific

Xuwei@lifetechmed.com

15695219339

Study Officials

• Wei Guo, Professor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 1, 2021
• Study Start: October 17, 2019
• Primary Completion: March 10, 2022
• Study Completion: March 22, 2022
• Last Updated: July 10, 2024
• Results First Posted: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)