Thoracoabdominal Aortic AneurysmNCT04731636
Guo's Visceral Arteries Reconstruction: First in Man Study
A study testing Thoracoabdominal aortic stent system in people with Thoracoabdominal Aortic Aneurysm and Pararenal Aortic Aneurysm, 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 thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysm. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm, Pararenal Aortic Aneurysm
- 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
- 15 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2019to 22 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 type Crawford I-V thoracoabdominal aortic aneurysmsa and pararenal abdominal aortic aneurysm, and should meet at least one of the following conditions:
- The maximum diameter of thoracoabdominal aortic aneurysms and pararenal abdorminal aortic aneurysm > 50 mm;
- Rapid growth of sac >5 mm in diameter in the most recent 6 months;
- Definite symptoms of abdominal pain and low back pain associated with thoracicabdominal aortic aneurysms.
- Patients with four indispensable reno-visceral arteries including superior mesenteric artery, celiac trunk and bilaterial renal arteries.
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- Proximal landing zone 20-36 mm in diameter;
- Proximal landing zone ≥25 mm in length;
- If distal landing zone in abdominal aorta, distal landing zone should be 12-36mm in diameter and ≥15 mm in length.
- The visceral vascular branches landing zone 6~13 mm in diameter and ≥15 mm in length;
- The renal artery landing zone 4.5~9 mm in diameter and ≥15 mm in length;
- Patients who using the abdominal aortic bifurcation stent graft system should also meet the following criteria:
- The ilac artery landing zone 7 ~25 mm in diameter;
- The ilac artery landing zone ≥15 mm in length;
- Patients with appropriate iliacofemoral access and at least one patent upper extremity access;
- Patients who can understand the purpose of the trial, volunntarily 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;
- Requiring simultaneous coverage or embolisation for bilateral internal iliac arteries;
- Severe stenosis, calcification, or mural thrombus at stent-graft landing zone;
- Diagnosis of acute coronary syndrome within 6 months;
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- Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months;
- An allergic history for contrast agents, anticoagulants, antiplatelet drugs, stent graft or materials of delivery system；
- Patients with connective tissue diseases;
- Patients with takayasu arteritis;
- Patients with serious vital organ dysfunction or other serious disease;
- 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;
- Patients whose systemic or local infection may increase the risk of intravascular graft infection;
- 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 not appropriate for endovascular repair based on the investigators' clinical judgement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guo's Visceral Arteries Reconstruction :The First in Man Study of G-Branch Multiple Branch Stent Graft System.
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysm.
Read the detailed description
The study is mainly for patients with Crawford type I-V thoracoabdominal aortic aneurysms and pararenal abdominal aortic 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
- Guo's Visceral Arteries Reconstruction, Thoracoabdominal aortic stent system, Thoracoabdominal Aortic Aneurysms, G-Branch, Pararenal abdominal 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.
Thoracoabdominal aortic stent systemDevice
Patients who meet all inclusion criteria and don't meet any exclusion criteria were implanted with thoracoabdominal aortic stent system.
| Study group | Role | What they receive |
|---|---|---|
| G-Branch Thoracoabdominal Aortic Stent System | Experimental | Patients with Crawford type I-V thoracoabdominal aortic aneurysms and Pararenal abdominal aortic aneurysm, and passed the screening and signed the Informed Consent Form Receives: Device: Thoracoabdominal aortic stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Major Adverse Events (MAE) Within 30 Days Postoperative
Major Adverse events (MAE) are defined as all-cause death, liver failure, intestinal necrosis, splenic infarction, renal infarction, renal failure, cerebral infarction, paraplegia, myocardial infarction, and respiratory 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 posted1 Feb 2021
- Study start17 Oct 2019
- Primary completion10 Mar 2022
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
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
- NCT04731636
- Sponsor's protocol ID
- TAAA-FIM-001
- Status last verified
- Jul 2024
- First submitted
- 26 Jan 2021
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang HP, Ge YY, Wang JB, Fan TT, Guo W. Off the Shelf Multibranched Endograft for Thoraco-Abdominal and Pararenal Abdominal Aortic Aneurysms: a Prospective, Single Centre Study of the G-Branch Endograft. Eur J Vasc Endovasc Surg. 2024 Mar;67(3):417-425. doi: 10.1016/j.ejvs.2023.11.005. Epub 2023 Nov 4.
PubMed 37926150
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guo's Visceral Arteries Reconstruction :The First in Man Study of G-Branch Multiple Branch Stent Graft System.
- ClinicalTrials.gov ID
- NCT04731636
- Acronym / sponsor ID
- TAAA-FIM-001
- Keywords
- Guo's Visceral Arteries Reconstruction, Thoracoabdominal aortic stent system, Thoracoabdominal Aortic Aneurysms, G-Branch, Pararenal abdominal aortic aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Posted 10 Jul 2024
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 thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysm.
Detailed description
The study is mainly for patients with Crawford type I-V thoracoabdominal aortic aneurysms and pararenal abdominal aortic 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 |
|---|---|---|
| G-Branch Thoracoabdominal Aortic Stent System | Experimental | Device: Thoracoabdominal aortic stent systemPatients with Crawford type I-V thoracoabdominal aortic aneurysms and Pararenal abdominal aortic aneurysm, 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 (16 listed)
- Age ≥18 and ≤80 years;
- Patients diagnosed with type Crawford I-V thoracoabdominal aortic aneurysmsa and pararenal abdominal aortic aneurysm, and should meet at least one of the following conditions:
- Patients with four indispensable reno-visceral arteries including superior mesenteric artery, celiac trunk and bilaterial renal arteries.
- Proximal landing zone 20-36 mm in diameter;
- Proximal landing zone ≥25 mm in length;
Key exclusion criteria (20 listed)
- Ruptured aortic aneurysm in unstable haemodynamic condition;
- Aneurysmal aortic dissection;
- Infected or mycotic aortic aneurysm;
- Requiring simultaneous coverage or embolisation for bilateral internal iliac arteries;
- Severe stenosis, calcification, or mural thrombus at stent-graft landing zone;
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 inclusion criteria and don't meet any exclusion criteria were implanted with thoracoabdominal aortic stent system. | Device | G-Branch Thoracoabdominal Aortic Stent System |
Primary outcome
Number of Participants With Major Adverse Events (MAE) Within 30 Days Postoperative
Time frame: within 30-days postoperative
Major Adverse events (MAE) are defined as all-cause death, liver failure, intestinal necrosis, splenic infarction, renal infarction, renal failure, cerebral infarction, paraplegia, myocardial infarction, and respiratory failure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37926150Zhang HP, Ge YY, Wang JB, Fan TT, Guo W. Off the Shelf Multibranched Endograft for Thoraco-Abdominal and Pararenal Abdominal Aortic Aneurysms: a Prospective, Single Centre Study of the G-Branch Endograft. Eur J Vasc Endovasc Surg. 2024 Mar;67(3):417-425. doi: 10.1016/j.ejvs.2023.11.005. Epub 2023 Nov 4.
- 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. This study is not recruiting at the moment.
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 and Pararenal 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 16 inclusion and 20 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: finished, as of the sponsor's last update on 10 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?
Yes. Results are posted in the registry (first posted 10 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With 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?
On the ClinicalTrials.gov record for NCT04731636, 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 10 Jul 2024.