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Outcome Measures

Primary Outcomes (2)

Treatment success rate
Treatment success is a composite index that should meet all of the following criteria: * Immediate technical success: refers to successful delivery of the delivery system to the intended location, successful deployment of the stent graft, withdrawal of the delivery system, with no type I/III endoleak) \[Timeframe: intraoperative\], * No TAAA-related secondary intervention (including secondary intervention due to aneurysm rupture, sustained enlargement, stent migration, type I/III endoleak, branch stenosis/occlusion) \[Timeframe: 12-month post operation\].
Intraoperative and 12-month post operation
Incidence of major adverse events (MAEs): 30-day post operation
MAEs are defined as all-cause death, hepatic failure, bowel necrosis, renal failure, stroke, permanent paraplegia, myocardial infarction, and respiratory failure.
30-day post operation

Secondary Outcomes (10)

Incidence of perioperative delivery system-related complications
intraoperative and within 30-day post operation
All-cause mortality
6-month, 12-month, and 2- to 5-year post operation
TAAA-related mortality
6-month, 12-month, and 2- to 5-year post operation
Incidence of serious adverse events (SAEs)
6-month, 12-month, and 2- to 5-year post operation
Incidence of device-related adverse events
6-month, 12-month, and 2- to 5-year post operation
+5 more secondary outcomes

Study Arms (1)

Endovascular therapy used as treatment of TAAA

EXPERIMENTAL

Traditional methods of treatment of TAAA include open surgery and hybrid surgery. Open surgery requires Thoracoabdominal incision which will result in a huge wound and the reconstruction of the visceral artery is also complicated. endovascular therapy has been developed for many years and has demonstrated significant advantages, such as small wounds, and fewer complications. Now Endovascular therapy is gradually used in the treatment of TAAA as well. Compared with traditional open surgery and hybrid surgery, the risk-benefit ratio of endovascular therapy is much better. When the risk-benefit gap between the investigational device and existing treatments is so wide that a control group is ethically unfeasible. So a single-arm exploratory study is adopted.

Device: The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system

Interventions

The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft systemDevice

The thoracoabdominal artery stent graft system is a mixed branch design with two inner branches for the visceral arteries and two outer branches for the bilateral renal arteries.

Endovascular therapy used as treatment of TAAA

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Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age: 18 to 80 years old;
Patients diagnosed with a Thoracoabdominal aortic aneurysm (based on the modified Crawford classification and European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms), and should meet at least ONE of the following conditions:

Study Design

Study Type

interventional

Phase

not applicable

Allocation

Masking

NONE

Purpose

DEVICE FEASIBILITY

Intervention Model

SINGLE GROUP

Model Details: Thoracoabdominal Artery Stent Graft System. The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system.

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

Thoracoabdominal Artery Stent Graft System Exploratory Study

Brief Summary

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Primary Completion

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Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Study Arms (1)

Endovascular therapy used as treatment of TAAA

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

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Conditions

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Source record

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Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Study Arms (1)

Endovascular therapy used as treatment of TAAA

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations