Thoracoabdominal Aortic AneurysmNCT06478576
Study on Multibranched Stent Graft System in the Treatment of Thoracoabdominal Aortic Aneurysm
A study testing multibranched stent graft system in people with Thoracoabdominal Aortic Aneurysm, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in China.
Trial summary
The objective of this study is to evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm
- What is being tested?
- multibranched 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
- 1 Jun 2023to 30 May 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
- Age ≥18 and ≤80 years;
- Patients diagnosed with thoracoabdominal aortic aneurysm (based on the modified Crawford classification and the 2019 European guidelines for the treatment of aortic aneurysms), and should meet at least one of the following conditions:
- Maximum diameter of TAAA >50 mm,
- Rapid growth of sac >5 mm in diameter in the most recent 6 months, or rapid growth >10 mm in diameter within 1 year
- Symptoms related to thoracoabdominal aortic aneurysm, such as clear abdominal pain and back pain.
- Anatomical criteria, including:
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- Proximal landing zone 17-36 mm in diameter and ≥25 mm in length
- If distal landing zone in abdominal aorta:Distal landing zone 12-36 mm in diameter and ≥20 mm in length If distal landing zone in iliac artery:Distal landing zone 7-25 mm in diameter and ≥15 mm in length
- Visceral vessel landing zone 6-13 mm in diameter and ≥15 mm in length
- Renal artery landing zone 4.5-9 mm in diameter and ≥15 mm in length
- Patients with Feasible iliofemoral artery and upper patent upper extremity access;
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to complete the follow-up according to the requirements of the protocol;
Who cannot join
- Ruptured aortic aneurysm in unstable haemodynamic condition;
- Aneurysmal aortic dissection;
- Infected or mycotic aortic aneurysm;
- Patients whose systemic or local infection may increase the risk of intravascular graft infection;
- Patients with occlusion of the superior mesenteric artery, celiac trunk, or renal artery.
- Requiring simultaneous coverage or embolisation for bilateral internal iliac arteries;
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- Severe stenosis, calcification, or mural thrombus at stent-graft landing zone;
- Diagnosis of acute coronary syndrome within 6 months; Acute coronary syndrome refers to an acute cardiac ischemia syndrome caused by the rupture or erosion of unstable atherosclerotic plaques in the coronary arteries, which is followed by the formation of fresh thrombus. It includes ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris.
- Patients with any transient ischemic attack (TIA) or ischemic 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;
- An allergic history for contrast agents, anticoagulants, antiplatelet drugs, stent graft or materials of delivery system( (referring to nickel-titanium, polyester, PTFE, nylon-based polymer materials);
- Patients with connective tissue diseases, such as systemic lupus erythematosus, Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease;
- Patients with takayasu arteritis;
- Patients with serious vital organ dysfunction or other serious disease;
- Planning pregnancy, pregnancy, or breastfeeding;
- The patient participated in other clinical trials or not completed or withdrawn from other clinical trials within the last 3 months at the time of screening period ;
- Life expectancy less than 1 year;
- Patients who are not appropriate for endovascular repair based on the investigators' clinical judgement.
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
Wei Guo, Professor
Wei Guo
About this study
Official title: GUo's Renovisceral Artery Reconstruction-2: a Prospective,Single Center,Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a multibRANched sTEnt Graft systEm for Thoracoabdominal Aortic Aneurysm
The objective of this study is to evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA)
Read the detailed description
The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Being tested
- multibranched stent graft system
- Keywords
- Lifetech, multibranched stent graft system, Endovascular Treatment
- 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.
multibranched stent graft systemDevice
To evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA)
| Study group | Role | What they receive |
|---|---|---|
| multibranched stent graft system | Experimental | Endovascular treatment of patients withThoracoabdominal Aortic Aneurysm using multibranched stent graft system Receives: Device: multibranched stent graft 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 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 postoperative
The success rate of thoracic and abdominal aortic aneurysm treatment after 12 months of surgery
Successful treatment of thoracoabdominal aortic aneurysm is a composite endpoint that requires meeting the following indicators at the same time: immediate technical success (immediate technical success refers to the successful delivery of the delivery system to the predetermined position, successful deployment of the system, safe withdrawal of the delivery system from the body, and no type I/III endoleak), and no secondary surgical intervention related to thoracoabdominal aortic aneurysm within 12 months after surgery (secondary surgery caused by aneurysm rupture, continuous enlargement, stent migration, type I/III endoleak, branch vessel stenosis/occlusion).
Measured: Intraoperative and 12 months postoperatively
Secondary outcomes (10)
Delivery system-related complications during perioperative period (from surgery to 30 days after surgery)
The incidence rate of related complications during the perioperative period (from surgery to 30 days after surgery), including intraoperative transition surgeries caused by delivery devices, bleeding, hematoma, and pseudoaneurysm during the delivery access route.
Measured: perioperative period (from surgery to 30 days after surgery)
All-cause mortality at 6 months and 12 months postoperatively
All-cause mortality refers to death from any cause that occurs within the follow-up time period.
Measured: 6 months and 12 months postoperatively
Mortality Rate Related to Thoracoabdominal Aortic Aneurysm at 6 months and 12 months postoperatively
Mortality related to thoracoabdominal aortic aneurysm refers to death caused by the rupture of the thoracoabdominal aortic aneurysm or surgery for the treatment of the thoracoabdominal aortic aneurysm.
Measured: 6 months and 12 months postoperatively
Incidence of severe adverse events at 6 and 12 months postoperatively
A serious adverse event refers to any occurrence during a clinical trial that leads to death or a serious deterioration in health status, including fatal illnesses or injuries, permanent defects in physical structure or function, the need for hospitalization or prolongation of hospital stay, the need for medical or surgical intervention to prevent permanent defects in physical structure or function, or events leading to fetal distress, fetal death, or congenital abnormalities or defects.
Measured: 6 months and 12 months postoperatively
Device-related adverse events at 6 months and 12 months postoperatively
Adverse events refers to an unfavorable medical event that occurs during a clinical trial, regardless of whether it is related to the medical device being tested. However, it should be distinguished from normal postoperative stress reactions, such as fever and constipation. If the researcher determines that they are normal postoperative stress reactions, they do not need to be recorded as adverse events. If the surgeon chooses staged reconstruction due to the subject's medical condition, it does not constitute an adverse event.
Measured: 6 months and 12 months postoperatively
Incidence rate of aneurysmal enlargement at 6 and 12 months postoperatively
aneurysmal enlargement defined as a maximum aortic diameter increase of > 5 mm
Measured: 6 and 12 months postoperatively
Incidence rate of Type I/III endoleak at 6 and 12 months postoperatively
Type I endoleak, also known as peri-graft endoleak or graft-related endoleak, refers to the leakage caused by the inability of the stent graft to tightly adhere to the autologous vessel, leading to continuous blood flow into the aneurysm sac. This includes proximal and distal Type I endoleaks. Type III endoleak refers to the leakage caused by the inability of the stent graft's own connectors to tightly adhere or the rupture of the artificial vessel, which results in continuous blood flow into the aneurysm sac.
Measured: 6 and 12 months postoperatively
Incidence rate of Stent graft migration at 6 and 12 months postoperatively
The evaluation criteria are: at the postoperative follow-up nodes, the position shift of the thoracoabdominal aortic covered stent is greater than 10mm compared to before discharge, or the shift causes symptoms or requires intervention.
Measured: 6 and 12 months postoperatively
The patency rate of the renovisceral artery at 6 and 12 months postoperatively
branch vessel patency is defined as stenosis of ≤50%
Measured: 6 and 12 months postoperatively
Incidence of secondary surgical interventions related to the Thoracoabdominal Aortic Aneurysm at 6 and 12 months postoperatively
Notes: Due to the patient's condition, the surgeon's choice of staged reconstruction does not constitute a secondary surgical intervention.
Measured: 6 and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Jun 2023
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal Aortic AneurysmStudies 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
- Other
- 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
- Principal investigator, XuWei, Lifetech Scientific (Shenzhen) Co., Ltd.
- Investigators
- Wei Guo, Professor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478576
- Sponsor's protocol ID
- XJ-TAAA-02
- Status last verified
- Jul 2024
- First submitted
- 24 Jun 2024
- Last updated
- 12 Jul 2024
- 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 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GUo's Renovisceral Artery Reconstruction-2: a Prospective,Single Center,Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a multibRANched sTEnt Graft systEm for Thoracoabdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT06478576
- Acronym / sponsor ID
- XJ-TAAA-02
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Keywords
- Lifetech, multibranched stent graft system, Endovascular Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 27 Jun 2024 (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.
The objective of this study is to evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA)
Detailed description
The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multibranched stent graft system | Experimental | Device: multibranched stent graft 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 (12 listed)
- Age ≥18 and ≤80 years;
- Patients diagnosed with thoracoabdominal aortic aneurysm (based on the modified Crawford classification and the 2019 European guidelines for the treatment of aortic aneurysms), and should meet at least one of the following conditions:
- Anatomical criteria, including:
- Patients with Feasible iliofemoral artery and upper patent upper extremity access;
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to complete the follow-up according to the requirements of the protocol;
Key exclusion criteria (21 listed)
- Ruptured aortic aneurysm in unstable haemodynamic condition;
- Aneurysmal aortic dissection;
- Infected or mycotic aortic aneurysm;
- Patients whose systemic or local infection may increase the risk of intravascular graft infection;
- Patients with occlusion of the superior mesenteric artery, celiac trunk, or renal artery.
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 |
|---|---|---|
| multibranched stent graft systemTo evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA) | Device | multibranched stent graft system |
Primary outcome
The Incidence of Major Adverse Events (MAE) Within 30 Days Postoperative
Time frame: within 30 days postoperative
Major Adverse Event (MAE) was defined as all-cause death, liver failure, intestinal necrosis, kidney failure, stroke, permanent paraplegia, myocardial infarction, and respiratory failure
The success rate of thoracic and abdominal aortic aneurysm treatment after 12 months of surgery
Time frame: Intraoperative and 12 months postoperatively
Successful treatment of thoracoabdominal aortic aneurysm is a composite endpoint that requires meeting the following indicators at the same time: immediate technical success (immediate technical success refers to the successful delivery of the delivery system to the predetermined position, successful deployment of the system, safe withdrawal of the delivery system from the body, and no type I/III endoleak), and no secondary surgical intervention related to thoracoabdominal aortic aneurysm within 12 months after surgery (secondary surgery caused by aneurysm rupture, continuous enlargement, stent migration, type I/III endoleak, branch vessel stenosis/occlusion).
10 secondary outcomes
Delivery system-related complications during perioperative period (from surgery to 30 days after surgery)
Time frame: perioperative period (from surgery to 30 days after surgery)
All-cause mortality at 6 months and 12 months postoperatively
Time frame: 6 months and 12 months postoperatively
Mortality Rate Related to Thoracoabdominal Aortic Aneurysm at 6 months and 12 months postoperatively
Time frame: 6 months and 12 months postoperatively
Incidence of severe adverse events at 6 and 12 months postoperatively
Time frame: 6 months and 12 months postoperatively
Device-related adverse events at 6 months and 12 months postoperatively
Time frame: 6 months and 12 months postoperatively
Incidence rate of aneurysmal enlargement at 6 and 12 months postoperatively
Time frame: 6 and 12 months postoperatively
Incidence rate of Type I/III endoleak at 6 and 12 months postoperatively
Time frame: 6 and 12 months postoperatively
Incidence rate of Stent graft migration at 6 and 12 months postoperatively
Time frame: 6 and 12 months postoperatively
The patency rate of the renovisceral artery at 6 and 12 months postoperatively
Time frame: 6 and 12 months postoperatively
Incidence of secondary surgical interventions related to the Thoracoabdominal Aortic Aneurysm at 6 and 12 months postoperatively
Time frame: 6 and 12 months 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 12 Jul 2024.
- 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 multibranched stent graft system in people with Thoracoabdominal Aortic Aneurysm, 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 12 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 12 Jul 2024. 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, PM (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). 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?
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 12 Jul 2024.