An interventional study of The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system in Thoracoabdominal Aortic Aneurysms, sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Lifetech Scientific (Shenzhen) Co., Ltd. (part of LifeTech Scientific Corporation) · Not applicable, Interventional, and Device feasibility
This study is designed as a single-center, prospective, single-arm, open-label, exploratory study. The objective is to evaluate the feasibility of Thoracoabdominal Artery Stent Graft System for endovascular treatment of Thoracoabdominal aortic aneurysms (TAAA).
Thoracoabdominal Aortic Aneurysms involve both thoracic and abdominal aortic arteries, as well as abdominal aortic aneurysms above the renal arteries. The treatment of TAAAs is complicated because the disease involves multiple visceral arteries. Traditional methods of treatment of TAAA include open surgery and hybrid surgery. The early postoperative mortality, as well as postoperative complications such as respiratory failure, renal failure, and other vital organ complications are concern for open surgery, which makes the benefit-risk ratio of traditional open surgery remains unsatisfactory. In addition, open surgery requires thoracoabdominal incision which will result in huge wound and the reconstruction of visceral artery is also complicated. Hybrid surgery, comprised of an initial open visceral debranching procedure followed by endovascular aneurysm exclusion, is another treatment option. Although hybrid surgery can reduce the huge wound caused by thoracotomy, it does not seem to result in lower complication rates at early and midterm follow up.
With the rapid development of endovascular treatment technology, endovascular therapy is also applied in the treatment of TAAA, and gradually becomes one of the main treatment method. Especially for patients with high surgical risk because of comorbidities, an endovascular solution may be preferable. Total endovascular aneurysm repair (t-EVAR) without debranching surgery does not require thoracotomy and laparotomy and could improve the outcomes of these patients. t-EVAR includes fenestrated EVAR (f-EVAR), multi-branched EVAR (b-EVAR), and physician-modified fenestration endograft (PMFG). Compared with open surgery and hybrid surgery, endovascular therapy has the following advantages: 1) minimally invasive surgery, avoiding thoracic and abdominal incision; 2) avoiding aorta occlusion during the operation so that reduce various visceral ischemia complications; 3) reducing intraoperative blood loss and hospital stay; 4) reducing spinal cord complications.
The TAAA stent graft system used for endovascular treatment generally consists of a stent graft and a delivery system. Stent graft, also known as artificial stent-type vascular graft, is generally composed of tubular covered and metal wire braided stent. The stent can be compressed into the sheath which delivers the stent to the lesion site of TAAA, and then is released from the sheath. The stent opens by its own expansion force to separate the blood from the lesion site, so as to achieve the treatment purpose. Custom made stents need to be designed and manufactured according to the patient's aortic characteristics, and the 6-8 week waiting period limits its use in patients who show precursors to rupture or who have already ruptured. Currently commercially available off-the-shelf multibranched stent grafts for TAAA include Zenith t-Branch stent (Cook), E-nside TAAA Multibranch Stent Graft System (Jotec) and GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Gore \& Associates). A critical issue with these multibranched stent grafts is the limited device specification and suboptimal anatomical feasibility for TAAA patients, therefore, improvements to the device profile, configuration and size optimization are needed. In the current context, Lifetech have developed a new TAAA stent graft system, Thoracoabdominal Artery Stent Graft System, which is a mixed branch design with two inner branches for the visceral arteries and two outer branches for the bilateral renal arteries. It is an off-the-shelf multibranched endograft and there is no need to waste time on customisation. The variations in the main body diameter, length and branch size, introducing diversified configurations that accommodate more anatomic conditions. Two inner branches are integrated with preloaded guidewires to facilitate visceral artery cannulation and reduce the procedure time. The semi-release design allows the stent position to be adjusted during the release process, making the stent positioning more accurate and less difficult.
This study is an exploratory study aimed to assess the feasibility of the Thoracoabdominal Artery Stent Graft System.
63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.
This study's planned enrollment of 11 is below the median of 80 across 41 interventional studies indexed under Aortic Aneurysm, Thoracoabdominal.
Browse Aortic Aneurysm, Thoracoabdominal studies →Lifetech Scientific (Shenzhen) Co., Ltd. is the lead sponsor of 44 studies on the registry; 17 are open to participants now.
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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:
Anatomical Criteria
Exclusion Criteria:
Exclusion Criteria (not eligible if any of the criteria is met):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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) \[Timeframe: 12-month post operation\].
Time frame: 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.
Time frame: 30-day post operation
Incidence of perioperative delivery system-related complications
Include conversion to open surgery, hemorrhage, hematoma, and pseudoaneurysm of the atrial access.
Time frame: intraoperative and within 30-day post operation
All-cause mortality
All-cause death is defined as death from any cause during the follow-up period.
Time frame: 6-month, 12-month, and 2- to 5-year post operation
TAAA-related mortality
TAAA-related death is defined as death due to rupture of TAAA or surgical treatment of TAAA.
Time frame: 6-month, 12-month, and 2- to 5-year post operation
Incidence of serious adverse events (SAEs)
If staged reconstruction is performed because of the patient's condition, then the reconstruction should not be a serious adverse event.
Time frame: 6-month, 12-month, and 2- to 5-year post operation
Incidence of device-related adverse events
Adverse events refer to adverse medical events that occur during a clinical trial, regardless of whether they are related to the investigational device. However, normal postoperative stress reactions, such as fever and constipation, should be distinguished. If events are judged by the investigator as normal postoperative stress reactions, they need not be recorded as adverse events. If staged reconstruction is chosen because of the patient's condition, then the reconstruction should not be an adverse event.
Time frame: 6-month, 12-month, and 2- to 5-year post operation
Incidence of increase in maximum diameter of aneurysm >5mm
Time frame: 6-month, 12-month post operation
Incidence of type I or III endoleaks
Time frame: 6-month, 12-month post operation
Incidence of stent graft migration
The evaluation criteria are as follows: 1) the stent graft migration at the follow-up point after operation is more than 10mm compared with the position before discharge, or 2) the migration caused symptoms or required intervention.
Time frame: 6-month, 12-month post operation
Patency rate of branch vessels
Patency of branch vessels is defined as stenosis ≤50% of the branch vessels.
Time frame: 6-month, 12-month post operation
Incidence of TAAA-related secondary intervention
If staged reconstruction is performed because of the patient's condition, then the reconstruction should not be a secondary intervention.
Time frame: 6-month, 12-month, and 2- to 5-year post operation
Started Jul 2025 (actual). Primary completion is estimated for Jun 2028, 35 months after the start.
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