An interventional study of Multi-Branched Thoracoabdominal Stent Graft System in Thoracoabdominal Aortic Aneurysms, sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-22.
Sponsored by Lifetech Scientific (Shenzhen) Co., Ltd. (part of LifeTech Scientific Corporation) · Not applicable, Interventional, and Treatment
Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.
The study is mainly for patients with thoracoabdominal aortic aneurysms, and all subjects who signed the informed consent and passed the screening will be enrolled. Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with multi-branched thoracoabdominal stent graft system. Patients will be followed up at discharge, 1 month, 6 months, 12 months after the implantation.
63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.
This study's planned enrollment of 73 is close to 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.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosed as thoracoabdominal aortic aneurysm (based on modified Crawford classification and 2019 European Guidelines for the Treatment of Aortic aneurysm) and should meet at least one of the following conditions;
anatomical criteria
Exclusion Criteria:
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with thoracoabdominal aortic aneurysms, and passed the screening and signed the informed consent form.
Device: Multi-Branched Thoracoabdominal Stent Graft System
Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with multi-branched thoracoabdominal stent graft system .
Primary safety endpoint: The incidence of Major Adverse events (MAE) within 30 days after procedure.
Major Adverse Event (MAE) was defined as all-cause death, liver failure, intestinal necrosis, kidney failure, stroke, permanent paraplegia, myocardial infarction, and respiratory failure.
Time frame: Within 30 days after procedure
Primary efficacy endpoint: Success rate of thoracoabdominal aortic aneurysm treatment 12 months after procedure.
Successful treatment of thoracoabdominal aortic aneurysm is a composite index that needs to meet the following indicators at the same time: Immediate technical success (immediate technical success refers to the successful delivery system to a predetermined location, the successful deployment of the system and the safe withdrawal of the delivery system from the body and no type I/III endoleak), no secondary surgical intervention related to thoracoabdominal aortic aneurysms 12 months after procedure (due to aneurysm rupture, continuous enlargement, stent displacement, type I/III endoleak, branch stenosis/ Second surgery caused by occlusion) .
Time frame: 12 months after procedure.
aneurysmal enlargement at 6 and 12 months postoperatively
aneurysmal enlargement defined as a maximum aortic diameter increase of \> 5 mm relative to preoperative computed tomography angiography (CTA)
Time frame: 6 and 12 months postoperatively
type I/III endoleak at 6 and 12 months postoperatively
Time frame: 6 and 12 months postoperatively
stent graft migration at 6 and 12 months postoperatively
Time frame: 6 and 12 months postoperatively
renovisceral artery patency rate at 6 and 12 months postoperatively
Time frame: 6 and 12 months postoperatively
reintervention secondary to TAAA progression at 6 months, 12 months, and 2-5 years postoperatively.
Time frame: 6 months, 12 months, and 2-5 years postoperatively.
delivery system-related complications during the procedure and within 30 days postoperatively, including conversion to open surgery, and any hemorrhage, hematoma, or pseudoaneurysm of the arterial access
Time frame: during the procedure and within 30 days postoperatively
all-cause mortality at 6 months, 12 months, and 2-5 years postoperatively
Time frame: 6 months, 12 months, and 2-5 years postoperatively
TAAA-related mortality at 6 months, 12 months, and 2-5 years postoperatively
Time frame: 6 months, 12 months, and 2-5 years postoperatively
device-related adverse events at 6 months, 12 months, and 2-5 years postoperatively
Time frame: 6 months, 12 months, and 2-5 years postoperatively
severe adverse events resulting in death or serious deterioration of health at 6 months, 12 months, and 2-5 years postoperatively
Time frame: 6 months, 12 months, and 2-5 years postoperatively
Plan to share: No — The data will be shared for scientific purposes after the completion of the clinical trial. However, patients' electronic records and any CTA files are outside the scope of our data sharing policy. Researchers wanting to request data can submit a detailed application to the investigators. Data will be released depending on the scientific quality of the submitted request.
Started Nov 2021 (actual). Primary completion is estimated for Dec 2025, 49 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Aortic Aneurysm, Thoracoabdominal →
Lifetech Scientific (Shenzhen) Co., Ltd. →