Thoracoabdominal; Aortic, Aneurysm, DissectingNCT05803564
Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.
A study testing Thoracoabdominal aortic stent system in people with Thoracoabdominal; Aortic, Aneurysm, Dissecting, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in China.
Trial summary
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic dissecting aneurysm. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracoabdominal; Aortic, Aneurysm, Dissecting
- What is being tested?
- Thoracoabdominal aortic stent system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Oct 2027
- 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
- Patients aged greater than 18 years old and less than 80 years old;
- Patients diagnosed with thoraco-abdominal aortic dissecting aneurysm and at least one of the following conditions should be met:
- a)Maximum aneurysm diameter >50 mm; b）Increase in diameter by more than 5 mm in recent 6 months c）Symptoms such as abdominal pain and back pain associated with thoracic and abdominal aortic dissecting aneurysm were identified.
- d）Poor morphology of thoracic and abdominal aortic dissecting aneurysm; e）Aortic dissection tears to iliac artery resulting in common iliac artery dissection tumor diameter >40 mm;
- Anatomic criteria
- a)The diameter of the proximal anchoring area (aorta or implanted graft) ranged from 17~36 mm to ≥25 mm in length; b）Distal anchoring area (aorta or implanted graft): If distal anchoring area is in iliac artery, anchoring area diameter range 7~25 mm, length ≥15 mm; If the distal anchoring area is in the abdominal aorta, the anchoring area has a diameter of 12~36 mm and a length of ≥20 mm; c）There is a normal anchoring area at the distal end of the visceral branch vessel. The diameter range of the anchoring area is 6~13 mm and the length is ≥15 mm.
- d）Normal anchoring zone at distal renal artery, anchoring zone diameter 4.5~9 mm, length ≥15 mm; e）Suitable iliac, femoral, and upper limb arterial access.
- Patients who understand the purpose of the trial, volunteer to participate and sign the informed consent form, and are willing to complete follow-up as required by the protocol;
Who cannot join
- Patients with severe hematoma in aortic wall in proximal anchoring area of stent
- Patients requiring simultaneous coverage and embolization of bilateral internal iliac arteries;
- Patients with a history of acute coronary syndrome within 6 months; Acute coronary syndromes are cardiac acute ischemic syndromes resulting from rupture of an unstable atherosclerotic plaque in the coronary artery or erosion secondary to the formation of new blood 4 thrombus, including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, and unstable angina.
- Patients with a transient ischemic attack (TIA) or ischemic/hemorrhagic stroke within 3 months;
- Patients with preoperative hepatic and renal dysfunction [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the normal upper limit; Serum creatinine (Cr) >150u mol/L];
- Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia;
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- Patients with severe coagulopathy;
- Patients with a history of hypersensitivity to contrast agents, anticoagulants, antiplatelet agents, stent delivery devices (i.e., nitinol, polyester, PTFE, nylon polymer materials);
- Patients with connective tissue diseases such as systemic lupus erythematosus, Marfan syndrome, Egyptian syndrome, or Behcet's disease;
- Patients with arteritis;
- Patients with significant organ dysfunction or other serious disease;
- Women with planned pregnancy, pregnancy stage , or lactation;
- The patient participated in another clinical trial and was not out or withdrawn within the first 3 months of the screening period of this trial.
- Patients with a life expectancy of not more than 1 year;
- Patients judged by the investigator to be unsuitable for endovascular treatment;
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 Hospita
Beijing, Beijing Municipality
Wei Guo
About this study
Official title: Clinical Application of a New Technique of Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic dissecting aneurysm.
Read the detailed description
The study is mainly for patients with thoraco-abdominal aortic dissecting aneurysm, and all subjects who passed the screening and signed the informed consent will be enrolled. Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent system. Patients will be followed up at discharge, 1 month, 6 months, 12 months after the implantation.
- Being tested
- Thoracoabdominal aortic stent system
- Keywords
- Thoracoabdominal aortic stent system, thoracoabdominal aortic dissecting aneurysm, G-Branch
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoabdominal aortic stent systemDevice
Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent system.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Endovascular treatment of patients withThoracoabdominal Aortic Aneurysm using multibranched stent graft system Receives: Device: Thoracoabdominal aortic stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Major Adverse Events (MAE) Within 30 Days Postoperative
Major Adverse events (MAE) are defined as death related to thoracic and abdominal aortic dissecting aneurysms, stroke, permanent paraplegia, kidney failure, intestinal necrosis, myocardial infarction, respiratory failure, and liver failure.
Measured: within 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Oct 2021
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal; Aortic, Aneurysm, DissectingStudies 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
- 46 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
- NCT05803564
- Sponsor's protocol ID
- Guard-FIM-01
- Status last verified
- Jun 2025
- First submitted
- 26 Mar 2023
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Clinical Application of a New Technique of Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.
- ClinicalTrials.gov ID
- NCT05803564
- Acronym / sponsor ID
- Guard-FIM-01
- Keywords
- Thoracoabdominal aortic stent system, thoracoabdominal aortic dissecting aneurysm, G-Branch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 7 Apr 2023 (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.
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic dissecting aneurysm.
Detailed description
The study is mainly for patients with thoraco-abdominal aortic dissecting aneurysm, and all subjects who passed the screening and signed the informed consent will be enrolled. Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent 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: Thoracoabdominal aortic stent systemEndovascular treatment of patients withThoracoabdominal Aortic Aneurysm using multibranched stent graft system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged greater than 18 years old and less than 80 years old;
- Patients diagnosed with thoraco-abdominal aortic dissecting aneurysm and at least one of the following conditions should be met:
- a)Maximum aneurysm diameter >50 mm; b）Increase in diameter by more than 5 mm in recent 6 months c）Symptoms such as abdominal pain and back pain associated with thoracic and abdominal aortic dissecting aneurysm were identified.
- d）Poor morphology of thoracic and abdominal aortic dissecting aneurysm; e）Aortic dissection tears to iliac artery resulting in common iliac artery dissection tumor diameter >40 mm;
- Anatomic criteria
Key exclusion criteria (15 listed)
- Patients with severe hematoma in aortic wall in proximal anchoring area of stent
- Patients requiring simultaneous coverage and embolization of bilateral internal iliac arteries;
- Patients with a history of acute coronary syndrome within 6 months; Acute coronary syndromes are cardiac acute ischemic syndromes resulting from rupture of an unstable atherosclerotic plaque in the coronary artery or erosion secondary to the formation of new blood 4 thrombus, including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, and unstable angina.
- Patients with a transient ischemic attack (TIA) or ischemic/hemorrhagic stroke within 3 months;
- Patients with preoperative hepatic and renal dysfunction [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the normal upper limit; Serum creatinine (Cr) >150u mol/L];
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 |
|---|---|---|
| Thoracoabdominal aortic stent systemPatients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent system. | Device | Intervention arm |
Primary outcome
The Incidence of Major Adverse Events (MAE) Within 30 Days Postoperative
Time frame: within 30 days postoperative
Major Adverse events (MAE) are defined as death related to thoracic and abdominal aortic dissecting aneurysms, stroke, permanent paraplegia, kidney failure, intestinal necrosis, myocardial infarction, respiratory failure, and liver failure.
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.
- Individual participant dataSharing planned: No
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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 Thoracoabdominal aortic stent system in people with Thoracoabdominal; Aortic, Aneurysm, Dissecting, 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 8 inclusion and 15 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 Xu (15695219339 ext. 86, xuwei@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Major Adverse Events (MAE) Within 30 Days Postoperative (time frame: within 30 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.