Trial Outcomes & Findings for Guo's Visceral Arteries Reconstruction: First in Man Study (NCT NCT04731636)

Last Updated: 2024-07-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

within 30-days postoperative

Results posted on

2024-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Guo's Visceral Arteries Reconstruction: First in Man Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	G-Branch Thoracoabdominal Aortic Stent System n=15 Participants Patients with Crawford type I-V thoracoabdominal aortic aneurysms and Pararenal abdominal aortic aneurysm, and passed the screening and signed the Informed Consent Form. G-Branch thoracoabdominal aortic stent system: Patients who meet all inclusion criteria and don't meet any exclusion criteria were implanted with thoracoabdominal aortic stent system.
Age, Continuous	63.4 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment China	15 Participants n=5 Participants
Society for Vascular Surgery(SVS) score	6 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: within 30-days postoperative

Population: Total number of cases available for evaluation of adverse events.

Outcome measures

Outcome measures
Measure	G-Branch Thoracoabdominal Aortic Stent System n=15 Participants Patients with Crawford type I-V thoracoabdominal aortic aneurysms and Pararenal abdominal aortic aneurysm, and passed the screening and signed theInformed Consent Form. G-Branch thoracoabdominal aortic stent system: Patients who meet all the inclusion criteria and don't meet any exclusion criteria were planteded with thoracoabdominal aortic stent system.
Number of Participants With Major Adverse Events (MAE) Within 30 Days Postoperative	1 participants

Adverse Events

G-Branch Thoracoabdominal Aortic Stent System

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	G-Branch Thoracoabdominal Aortic Stent System n=15 participants at risk Patients with Crawford type I-V thoracoabdominal aortic aneurysms and Pararenal abdominal aortic aneurysm, and passed the screening and signed the informed consent form. 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.
Vascular disorders Died of acute cerebral infarction	6.7% 1/15 • Number of events 1 • 1 year
Renal and urinary disorders Renal insufficiency	6.7% 1/15 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure	G-Branch Thoracoabdominal Aortic Stent System n=15 participants at risk Patients with Crawford type I-V thoracoabdominal aortic aneurysms and Pararenal abdominal aortic aneurysm, and passed the screening and signed the informed consent form. 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.
Injury, poisoning and procedural complications Minor type II endoleak	13.3% 2/15 • Number of events 2 • 1 year

Additional Information

Clinical manager

LifeTechScientific

Phone: 15695219339

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place