Thoracoabdominal Aortic AneurysmsNCT05054985
Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.
A study testing Multi-Branched Thoracoabdominal Stent Graft System in people with Thoracoabdominal Aortic Aneurysms, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in China.
Trial summary
Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysms
- What is being tested?
- Multi-Branched Thoracoabdominal Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2021to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ age ≤ 80 years old;
- 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;
- Maximum diameter of thoracoabdominal aortic aneurysm>50mm;
- The diameter has increased by more than 5mm in recent 6 months or the by more than 10mm in recent 1 year;
- anatomical criteria
- The proximal anchoring region (aorta or implanted graft) was 17~36 mm in diameter and ≥25 mm in length;
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- Distal anchoring region (aorta or implanted graft): If the distal anchoring region is in the iliac artery, the anchoring region has a diameter range of 7~25 mm and a length of ≥15 mm; If the distal anchoring area is in the abdominal aorta, the diameter of the anchoring area ranges from 12~36mm and the length≥ 20mm;
- The diameter of the vessel anchoring area of the visceral branch ranges from 6~13 mm and the length ≥15 mm;
- The diameter of renal artery anchoring area ranges from 4.5~9mm, and the length ≥15 mm;
- Appropriate iliac, femoral and upper limb artery access;
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent, and are willing to complete the follow-up according to the requirements of the protocol;
Who cannot join
- Hemodynamically unstable patients with ruptured thoracoabdominal aortic aneurysms;
- Thoracoabdominal aortic dissection;
- Mycotic or infectious thoracoabdominal aortic aneurysm;
- Patients whose systemic or local infection may increase the risk of intravascular graft infection;
- Superior mesenteric, celiac, or renal artery occlusion;
- Requiring simultaneous coverage and embolization of bilateral internal iliac arteries;
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- Severe stenosis, calcification, or mural thrombus in the anchoring area of the stent tend to have difficulty in attachment of the stent-graft or affect the patency of the stent;
- A history of acute coronary syndrome within 6 months; Acute coronary syndrome is defined as an acute ischemic syndrome of the heart resulting from the rupture or erosion of unstable intracoronary atherosclerotic plaques followed by fresh thrombosis, including ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris.
- Transient ischemic attack (TIA) or ischemic/haemorrhagic stroke within 3 months;
- 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;
- A history of allergy to contrast agents, anticoagulants, antiplatelet drugs, stents, and conveyor materials (nitinol, polyester, PTFE, nylon);
- Connective tissue diseases such as systemic lupus erythematosus, Marfan's syndrome, Adam's syndrome, or Behcet's disease;
- takayasu arteritis;
- Serious vital organ dysfunction or other serious disease;
- Planning pregnancy, pregnancy, or breastfeeding;
- Patients who participated in other clinical trials and was not discontinued or withdrawn within the first 3 months of the screening period of this trial.
- Life expectancy less than 1 year;
- Patients who, in the judgment of the investigator, are not eligible for endotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality
Wei Guo
Wei Guo
About this study
Official title: Guo's Renovisceral Artery Reconstruction-1: a Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a Multi-branched Stent Graft System for Thoracoabdominal Aortic Aneurysm (GUARANTEE Study)
Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.
Read the detailed description
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.
- Conditions
- Thoracoabdominal Aortic Aneurysms
- Being tested
- Multi-Branched Thoracoabdominal Stent Graft System
- Keywords
- Guo's Visceral Arteries Reconstruction, Multi-branched Thoracoabdominal Stent Graft System, Thoracoabdominal Aortic Aneurysm
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Branched Thoracoabdominal Stent Graft SystemDevice
Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with multi-branched thoracoabdominal stent graft system .
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Patients with thoracoabdominal aortic aneurysms, and passed the screening and signed the informed consent form. Receives: Device: Multi-Branched Thoracoabdominal Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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) .
Measured: 12 months after procedure.
Secondary outcomes (10)
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)
Measured: 6 and 12 months postoperatively
type I/III endoleak at 6 and 12 months postoperatively
Measured: 6 and 12 months postoperatively
stent graft migration at 6 and 12 months postoperatively
Measured: 6 and 12 months postoperatively
renovisceral artery patency rate at 6 and 12 months postoperatively
Measured: 6 and 12 months postoperatively
reintervention secondary to TAAA progression at 6 months, 12 months, and 2-5 years postoperatively.
Measured: 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
Measured: during the procedure and within 30 days postoperatively
all-cause mortality at 6 months, 12 months, and 2-5 years postoperatively
Measured: 6 months, 12 months, and 2-5 years postoperatively
TAAA-related mortality at 6 months, 12 months, and 2-5 years postoperatively
Measured: 6 months, 12 months, and 2-5 years postoperatively
device-related adverse events at 6 months, 12 months, and 2-5 years postoperatively
Measured: 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
Measured: 6 months, 12 months, and 2-5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start12 Nov 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracoabdominal Aortic AneurysmsStudies of the same condition, open and under way.
- More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Guo, Professor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054985
- Sponsor's protocol ID
- XJ-TAAA-01
- Status last verified
- Jun 2025
- First submitted
- 7 Sep 2021
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Ge Y, Zhang H, Rong D, Liu F, Jia X, Xiong J, Ma X, Wang L, Fan T, Guo W. Protocol for GUo's renovisceral Artery reconstruction-1: a prospective, multicentre, single-arm clinical trial to evaluate the safety and efficacy of a multibRANched sTEnt graft systEm for thoracoabdominal aortic aneurysm (GUARANTEE study). BMJ Open. 2022 Mar 23;12(3):e059401. doi: 10.1136/bmjopen-2021-059401.
PubMed 35321900
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guo's Renovisceral Artery Reconstruction-1: a Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a Multi-branched Stent Graft System for Thoracoabdominal Aortic Aneurysm (GUARANTEE Study)
- ClinicalTrials.gov ID
- NCT05054985
- Acronym / sponsor ID
- XJ-TAAA-01
- Conditions
- Thoracoabdominal Aortic Aneurysms
- Keywords
- Guo's Visceral Arteries Reconstruction, Multi-branched Thoracoabdominal Stent Graft System, Thoracoabdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: Multi-Branched Thoracoabdominal Stent Graft SystemPatients with thoracoabdominal aortic aneurysms, and passed the screening and signed the informed consent form. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years old ≤ age ≤ 80 years old;
- 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
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent, and are willing to complete the follow-up according to the requirements of the protocol;
Key exclusion criteria (21 listed)
- Hemodynamically unstable patients with ruptured thoracoabdominal aortic aneurysms;
- Thoracoabdominal aortic dissection;
- Mycotic or infectious thoracoabdominal aortic aneurysm;
- Patients whose systemic or local infection may increase the risk of intravascular graft infection;
- Superior mesenteric, celiac, or renal artery occlusion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Branched Thoracoabdominal Stent Graft SystemPatients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with multi-branched thoracoabdominal stent graft system . | Device | Intervention arm |
Primary outcome
Primary safety endpoint: The incidence of Major Adverse events (MAE) within 30 days after procedure.
Time frame: 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.
Primary efficacy endpoint: Success rate of thoracoabdominal aortic aneurysm treatment 12 months after procedure.
Time frame: 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) .
10 secondary outcomes
aneurysmal enlargement at 6 and 12 months postoperatively
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Derived from this study: PubMed 35321900Ge Y, Zhang H, Rong D, Liu F, Jia X, Xiong J, Ma X, Wang L, Fan T, Guo W. Protocol for GUo's renovisceral Artery reconstruction-1: a prospective, multicentre, single-arm clinical trial to evaluate the safety and efficacy of a multibRANched sTEnt graft systEm for thoracoabdominal aortic aneurysm (GUARANTEE study). BMJ Open. 2022 Mar 23;12(3):e059401. doi: 10.1136/bmjopen-2021-059401.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Guo, Professor principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Branched Thoracoabdominal Stent Graft System in people with Thoracoabdominal Aortic Aneurysms, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Guo, Professor (13910758706 ext. 86, pla301dml@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpoint: The incidence of Major Adverse events (MAE) within 30 days after procedure. (time frame: Within 30 days after procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05054985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.