Thoracoabdominal Aortic AneurysmsNCT06710938
Thoracoabdominal Artery Stent Graft System Exploratory Study
A study testing The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system in people with Thoracoabdominal Aortic Aneurysms, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in Germany.
Trial summary
This study is designed as a single-center, prospective, single-arm, open-label, exploratory study. The objective is to evaluate the feasibility of Thoracoabdominal Artery Stent Graft System for endovascular treatment of Thoracoabdominal aortic aneurysms (TAAA). 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?
- The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jul 2025to 30 Jun 2032
- 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 to 80 years old;
- Patients diagnosed with a Thoracoabdominal aortic aneurysm (based on the modified Crawford classification and European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms), and should meet at least ONE of the following conditions:
- Maximum diameter of TAAA is >50 mm;
- TAAA diameter increases by more than 5 mm in the past 6 months or by more than 10 mm in the past 1 year;
- Definite symptoms associated with TAAA, such as abdominal pain and back pain.
- Anatomical Criteria
Show all 13Show fewer
- Proximal landing zone (aorta or implanted graft): the diameter ranges from 17 to 36 mm, and length should be ≥25 mm;
- Distal landing zone (aorta or implanted graft): If distal landing zone is in iliac artery, distal landing zone diameter ranges from 7 to 25 mm, and length should be ≥15 mm; If the distal landing zone is in the abdominal aorta, distal landing zone diameter ranges from 12 to 36 mm, and length should be ≥20 mm.
- Visceral branch landing zone: the diameter ranges from 6 to 13 mm, and the length should be ≥15 mm;
- Renal artery landing zone: the diameter ranges from 4.5 to 9 mm, and the length should be ≥15 mm;
- Appropriate iliac, femoral, and upper limb arterial access.
- Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up as required by the protocol;
- Patients do not want to or cannot wait for the approved alternative
Who cannot join
- Exclusion Criteria (not eligible if any of the criteria is met):
- Patients with ruptured thoracoabdominal aortic aneurysms in unstable hemodynamic condition;
- Patients with thoracoabdominal aortic dissection;
- Patients with infected or mycotic thoracoabdominal aortic aneurysms;
- Patients with systemic or local infections that may increase the risk of endovascular graft infection;
- Patients with occluded superior mesenteric artery, celiac trunk artery, or renal artery;
Show all 12Show fewer
- Patients requiring simultaneous coverage or embolization of bilateral internal iliac arteries;
- Patients with severe stenosis, calcification or mural thrombus at stent-graft landing zone, and this situation leads to difficulty in adhering the covered stent or affecting the patency of the stent;
- Patients with a history of acute coronary syndrome within the recent 6 months; Acute coronary syndrome refers to acute cardiac ischemic syndrome caused by rupture or erosion of unstable atherosclerotic plaques in the coronary artery and fresh thrombosis, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina pectoris.
- Patients with transient ischemic attack (TIA) or ischemic/hemorrhagic stroke within the recent 3 months;
- Patients with abnormal liver and kidney function before operation [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal value; Serum creatinine (Cr) >150umol/L];
- Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Asklepios Klinik Nord Heidberg
Hamburg
Marwan Youssef
About this study
Official title: Exploratory Study of Thoracoabdominal Artery Stent Graft System in the Treatment of Thoracoabdominal Aortic Aneurysms
This study is designed as a single-center, prospective, single-arm, open-label, exploratory study. The objective is to evaluate the feasibility of Thoracoabdominal Artery Stent Graft System for endovascular treatment of Thoracoabdominal aortic aneurysms (TAAA).
Read the detailed description
Thoracoabdominal Aortic Aneurysms involve both thoracic and abdominal aortic arteries, as well as abdominal aortic aneurysms above the renal arteries. The treatment of TAAAs is complicated because the disease involves multiple visceral arteries. Traditional methods of treatment of TAAA include open surgery and hybrid surgery. The early postoperative mortality, as well as postoperative complications such as respiratory failure, renal failure, and other vital organ complications are concern for open surgery, which makes the benefit-risk ratio of traditional open surgery remains unsatisfactory. In addition, open surgery requires thoracoabdominal incision which will result in huge wound and the reconstruction of visceral artery is also complicated. Hybrid surgery, comprised of an initial open visceral debranching procedure followed by endovascular aneurysm exclusion, is another treatment option. Although hybrid surgery can reduce the huge wound caused by thoracotomy, it does not seem to result in lower complication rates at early and midterm follow up.
With the rapid development of endovascular treatment technology, endovascular therapy is also applied in the treatment of TAAA, and gradually becomes one of the main treatment method. Especially for patients with high surgical risk because of comorbidities, an endovascular solution may be preferable. Total endovascular aneurysm repair (t-EVAR) without debranching surgery does not require thoracotomy and laparotomy and could improve the outcomes of these patients. t-EVAR includes fenestrated EVAR (f-EVAR), multi-branched EVAR (b-EVAR), and physician-modified fenestration endograft (PMFG). Compared with open surgery and hybrid surgery, endovascular therapy has the following advantages: 1) minimally invasive surgery, avoiding thoracic and abdominal incision; 2) avoiding aorta occlusion during the operation so that reduce various visceral ischemia complications; 3) reducing intraoperative blood loss and hospital stay; 4) reducing spinal cord complications.
The TAAA stent graft system used for endovascular treatment generally consists of a stent graft and a delivery system. Stent graft, also known as artificial stent-type vascular graft, is generally composed of tubular covered and metal wire braided stent. The stent can be compressed into the sheath which delivers the stent to the lesion site of TAAA, and then is released from the sheath. The stent opens by its own expansion force to separate the blood from the lesion site, so as to achieve the treatment purpose. Custom made stents need to be designed and manufactured according to the patient's aortic characteristics, and the 6-8 week waiting period limits its use in patients who show precursors to rupture or who have already ruptured. Currently commercially available off-the-shelf multibranched stent grafts for TAAA include Zenith t-Branch stent (Cook), E-nside TAAA Multibranch Stent Graft System (Jotec) and GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Gore \& Associates). A critical issue with these multibranched stent grafts is the limited device specification and suboptimal anatomical feasibility for TAAA patients, therefore, improvements to the device profile, configuration and size optimization are needed. In the current context, Lifetech have developed a new TAAA stent graft system, Thoracoabdominal Artery Stent Graft System, which is a mixed branch design with two inner branches for the visceral arteries and two outer branches for the bilateral renal arteries. It is an off-the-shelf multibranched endograft and there is no need to waste time on customisation. The variations in the main body diameter, length and branch size, introducing diversified configurations that accommodate more anatomic conditions. Two inner branches are integrated with preloaded guidewires to facilitate visceral artery cannulation and reduce the procedure time. The semi-release design allows the stent position to be adjusted during the release process, making the stent positioning more accurate and less difficult.
This study is an exploratory study aimed to assess the feasibility of the Thoracoabdominal Artery Stent Graft System.
- Conditions
- Thoracoabdominal Aortic Aneurysms
- Being tested
- The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system
- Keywords
- Thoracoabdominal Aortic Aneurysms, G-branch Stent Graft, Lifetech Scientific, Thoracoabdominal Artery Stent Graft System
- 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.
The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft systemDevice
The thoracoabdominal artery stent graft system is a mixed branch design with two inner branches for the visceral arteries and two outer branches for the bilateral renal arteries.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular therapy used as treatment of TAAA | Experimental | Traditional methods of treatment of TAAA include open surgery and hybrid surgery. Open surgery requires Thoracoabdominal incision which will result in a huge wound and the reconstruction of the visceral artery is also complicated. endovascular therapy has been developed for many years and has demonstrated significant advantages, such as small wounds, and fewer complications. Now Endovascular therapy is gradually used in the treatment of TAAA as well. Compared with traditional open surgery and hybrid surgery, the risk-benefit ratio of endovascular therapy is much better. When the risk-benefit gap between the investigational device and existing treatments is so wide that a control group is ethically unfeasible. So a single-arm exploratory study is adopted. Receives: Device: The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success rate
Treatment success is a composite index that should meet all of the following criteria:
- Immediate technical success: refers to successful delivery of the delivery system to the intended location, successful deployment of the stent graft, withdrawal of the delivery system, with no type I/III endoleak) [Timeframe: intraoperative],
- No TAAA-related secondary intervention (including secondary intervention due to aneurysm rupture, sustained enlargement, stent migration, type I/III endoleak, branch stenosis/occlusion) [Timeframe: 12-month post operation].
Measured: Intraoperative and 12-month post operation
Incidence of major adverse events (MAEs): 30-day post operation
MAEs are defined as all-cause death, hepatic failure, bowel necrosis, renal failure, stroke, permanent paraplegia, myocardial infarction, and respiratory failure.
Measured: 30-day post operation
Secondary outcomes (10)
Incidence of perioperative delivery system-related complications
Include conversion to open surgery, hemorrhage, hematoma, and pseudoaneurysm of the atrial access.
Measured: intraoperative and within 30-day post operation
All-cause mortality
All-cause death is defined as death from any cause during the follow-up period.
Measured: 6-month, 12-month, and 2- to 5-year post operation
TAAA-related mortality
TAAA-related death is defined as death due to rupture of TAAA or surgical treatment of TAAA.
Measured: 6-month, 12-month, and 2- to 5-year post operation
Incidence of serious adverse events (SAEs)
If staged reconstruction is performed because of the patient's condition, then the reconstruction should not be a serious adverse event.
Measured: 6-month, 12-month, and 2- to 5-year post operation
Incidence of device-related adverse events
Adverse events refer to adverse medical events that occur during a clinical trial, regardless of whether they are related to the investigational device. However, normal postoperative stress reactions, such as fever and constipation, should be distinguished. If events are judged by the investigator as normal postoperative stress reactions, they need not be recorded as adverse events. If staged reconstruction is chosen because of the patient's condition, then the reconstruction should not be an adverse event.
Measured: 6-month, 12-month, and 2- to 5-year post operation
Incidence of increase in maximum diameter of aneurysm >5mm
Measured: 6-month, 12-month post operation
Incidence of type I or III endoleaks
Measured: 6-month, 12-month post operation
Incidence of stent graft migration
The evaluation criteria are as follows: 1) the stent graft migration at the follow-up point after operation is more than 10mm compared with the position before discharge, or 2) the migration caused symptoms or required intervention.
Measured: 6-month, 12-month post operation
Patency rate of branch vessels
Patency of branch vessels is defined as stenosis ≤50% of the branch vessels.
Measured: 6-month, 12-month post operation
Incidence of TAAA-related secondary intervention
If staged reconstruction is performed because of the patient's condition, then the reconstruction should not be a secondary intervention.
Measured: 6-month, 12-month, and 2- to 5-year post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start24 Jul 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal Aortic AneurysmsStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Thoracoabdominal Artery Stent Graft System. The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system.
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710938
- Sponsor's protocol ID
- LT/TS-TAAA-EU-01
- Status last verified
- May 2026
- First submitted
- 15 Nov 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Thoracoabdominal Artery Stent Graft System in the Treatment of Thoracoabdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT06710938
- Acronym / sponsor ID
- LT/TS-TAAA-EU-01
- Conditions
- Thoracoabdominal Aortic Aneurysms
- Keywords
- Thoracoabdominal Aortic Aneurysms, G-branch Stent Graft, Lifetech Scientific, Thoracoabdominal Artery Stent Graft System
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 29 Nov 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.
This study is designed as a single-center, prospective, single-arm, open-label, exploratory study. The objective is to evaluate the feasibility of Thoracoabdominal Artery Stent Graft System for endovascular treatment of Thoracoabdominal aortic aneurysms (TAAA).
Detailed description
Thoracoabdominal Aortic Aneurysms involve both thoracic and abdominal aortic arteries, as well as abdominal aortic aneurysms above the renal arteries. The treatment of TAAAs is complicated because the disease involves multiple visceral arteries. Traditional methods of treatment of TAAA include open surgery and hybrid surgery. The early postoperative mortality, as well as postoperative complications such as respiratory failure, renal failure, and other vital organ complications are concern for open surgery, which makes the benefit-risk ratio of traditional open surgery remains unsatisfactory. In addition, open surgery requires thoracoabdominal incision which will result in huge wound and the reconstruction of visceral artery is also complicated. Hybrid surgery, comprised of an initial open visceral debranching procedure followed by endovascular aneurysm exclusion, is another treatment option. Although hybrid surgery can reduce the huge wound caused by thoracotomy, it does not seem to result in lower complication rates at early and midterm follow up.
With the rapid development of endovascular treatment technology, endovascular therapy is also applied in the treatment of TAAA, and gradually becomes one of the main treatment method. Especially for patients with high surgical risk because of comorbidities, an endovascular solution may be preferable. Total endovascular aneurysm repair (t-EVAR) without debranching surgery does not require thoracotomy and laparotomy and could improve the outcomes of these patients. t-EVAR includes fenestrated EVAR (f-EVAR), multi-branched EVAR (b-EVAR), and physician-modified fenestration endograft (PMFG). Compared with open surgery and hybrid surgery, endovascular therapy has the following advantages: 1) minimally invasive surgery, avoiding thoracic and abdominal incision; 2) avoiding aorta occlusion during the operation so that reduce various visceral ischemia complications; 3) reducing intraoperative blood loss and hospital stay; 4) reducing spinal cord complications.
The TAAA stent graft system used for endovascular treatment generally consists of a stent graft and a delivery system. Stent graft, also known as artificial stent-type vascular graft, is generally composed of tubular covered and metal wire braided stent. The stent can be compressed into the sheath which delivers the stent to the lesion site of TAAA, and then is released from the sheath. The stent opens by its own expansion force to separate the blood from the lesion site, so as to achieve the treatment purpose. Custom made stents need to be designed and manufactured according to the patient's aortic characteristics, and the 6-8 week waiting period limits its use in patients who show precursors to rupture or who have already ruptured. Currently commercially available off-the-shelf multibranched stent grafts for TAAA include Zenith t-Branch stent (Cook), E-nside TAAA Multibranch Stent Graft System (Jotec) and GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Gore \& Associates). A critical issue with these multibranched stent grafts is the limited device specification and suboptimal anatomical feasibility for TAAA patients, therefore, improvements to the device profile, configuration and size optimization are needed. In the current context, Lifetech have developed a new TAAA stent graft system, Thoracoabdominal Artery Stent Graft System, which is a mixed branch design with two inner branches for the visceral arteries and two outer branches for the bilateral renal arteries. It is an off-the-shelf multibranched endograft and there is no need to waste time on customisation. The variations in the main body diameter, length and branch size, introducing diversified configurations that accommodate more anatomic conditions. Two inner branches are integrated with preloaded guidewires to facilitate visceral artery cannulation and reduce the procedure time. The semi-release design allows the stent position to be adjusted during the release process, making the stent positioning more accurate and less difficult.
This study is an exploratory study aimed to assess the feasibility of the Thoracoabdominal Artery Stent Graft System.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Thoracoabdominal Artery Stent Graft System. The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system.
| Arm | Type | Receives |
|---|---|---|
| Endovascular therapy used as treatment of TAAA | Experimental | Device: The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft systemTraditional methods of treatment of TAAA include open surgery and hybrid surgery. Open surgery requires Thoracoabdominal incision which will result in a huge wound and the reconstruction of the visceral artery is also complicated. endovascular therapy has been developed for many years and has demonstrated significant advantages, such as small wounds, and fewer complications. Now Endovascular therapy is gradually used in the treatment of TAAA as well. Compared with traditional open surgery and hybrid surgery, the risk-benefit ratio of endovascular therapy is much better. When the risk-benefit gap between the investigational device and existing treatments is so wide that a control group is ethically unfeasible. So a single-arm exploratory study is adopted. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age: 18 to 80 years old;
- Patients diagnosed with a Thoracoabdominal aortic aneurysm (based on the modified Crawford classification and European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms), and should meet at least ONE of the following conditions:
- Anatomical Criteria
- Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up as required by the protocol;
- Patients do not want to or cannot wait for the approved alternative
Key exclusion criteria (12 listed)
- Patients with ruptured thoracoabdominal aortic aneurysms in unstable hemodynamic condition;
- Patients with thoracoabdominal aortic dissection;
- Patients with infected or mycotic thoracoabdominal aortic aneurysms;
- Patients with systemic or local infections that may increase the risk of endovascular graft infection;
- Patients with occluded superior mesenteric artery, celiac trunk artery, 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 |
|---|---|---|
| The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft systemThe thoracoabdominal artery stent graft system is a mixed branch design with two inner branches for the visceral arteries and two outer branches for the bilateral renal arteries. | Device | Endovascular therapy used as treatment of TAAA |
Primary outcome
Treatment success rate
Time frame: Intraoperative and 12-month post operation
Treatment success is a composite index that should meet all of the following criteria: * Immediate technical success: refers to successful delivery of the delivery system to the intended location, successful deployment of the stent graft, withdrawal of the delivery system, with no type I/III endoleak) [Timeframe: intraoperative], * No TAAA-related secondary intervention (including secondary intervention due to aneurysm rupture, sustained enlargement, stent migration, type I/III endoleak, branch stenosis/occlusion) [Timeframe: 12-month post operation].
Incidence of major adverse events (MAEs): 30-day post operation
Time frame: 30-day post operation
MAEs are defined as all-cause death, hepatic failure, bowel necrosis, renal failure, stroke, permanent paraplegia, myocardial infarction, and respiratory failure.
10 secondary outcomes
Incidence of perioperative delivery system-related complications
Time frame: intraoperative and within 30-day post operation
All-cause mortality
Time frame: 6-month, 12-month, and 2- to 5-year post operation
TAAA-related mortality
Time frame: 6-month, 12-month, and 2- to 5-year post operation
Incidence of serious adverse events (SAEs)
Time frame: 6-month, 12-month, and 2- to 5-year post operation
Incidence of device-related adverse events
Time frame: 6-month, 12-month, and 2- to 5-year post operation
Incidence of increase in maximum diameter of aneurysm >5mm
Time frame: 6-month, 12-month post operation
Incidence of type I or III endoleaks
Time frame: 6-month, 12-month post operation
Incidence of stent graft migration
Time frame: 6-month, 12-month post operation
Patency rate of branch vessels
Time frame: 6-month, 12-month post operation
Incidence of TAAA-related secondary intervention
Time frame: 6-month, 12-month, and 2- to 5-year post operation
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 26 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system in people with Thoracoabdominal Aortic Aneurysms, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in Germany.
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 13 inclusion and 12 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 26 May 2026. 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 Germany. 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 Rae Gong ((86-755)-86026250-6957, gongrui@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success rate (time frame: Intraoperative and 12-month post operation). 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 26 May 2026.