Aortic Dissection Type BSAFE-COVERNCT06892730
Safety and Efficacy of TEVAR Combined With Long Bare-metal Stents in the Intervention of ATBAD
A study testing Hybrid TEVAR combined with long bare-metal stent intervention in people with Aortic Dissection Type B, run by Yan'an Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the safety and efficacy of the TEVAR combined with extended bare-metal stenting (distal landing zone ≥2 cm below renal arteries) in patients with acute complicated type B aortic dissection (ATBAD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Dissection Type B
- What is being tested?
- Hybrid TEVAR combined with long bare-metal stent intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to 31 Mar 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
- ≧18 years old, ≦80 years old;
- Acute phase with a course of disease ≦14 days;
- CTA confirmed diagnosis of active dissection type B in accordance with the Stanford classification in the ESC guidelines, and requiring TEVAR surgery;
- For patients with acute non-type A and non-type B aortic dissection involving the left subclavian artery: current technologies (such as fenestration, single branch, chimney, etc.) can be used to solve the reconstruction of the left subclavian artery;
- The distal end of the dissection exceeds the renal artery plane;
- Signed informed consent (emergency waiver applicable), with primary intervention using CTAG devices. Adjunctive procedures may include LSA revascularization, percutaneous fenestration, aortic/peripheral stenting, surgical fenestration, or bypass grafting.
- Medical record completeness >90% with mandatory CTA data;
- Protocol compliance including follow-up adherence
Who cannot join
- Dissection termination above renal arteries;
- Major aortic surgery within 30 days prior (except LSA revascularization);
- Iliofemoral stenosis/angulation precluding endovascular access;
- Non-diagnostic CTA image quality;
- Indeterminate symptom onset time;
- Traumatic TBAD, intramural hematoma, or penetrating aortic ulcer;
Show all 19Show fewer
- Complete thoracic aortic thrombosis pre-TEVAR;
- Re-intervention within 12 months post-TEVAR for non-aortic indications;
- Renal failure: Baseline serum creatinine >2.5 mg/dL (high-risk for contrast nephropathy);
- Known device material hypersensitivity;
- Systemic infection increasing endograft infection risk;
- Evidence of aortic infection;
- Connective tissue disorders (e.g., Marfan syndrome);
- Bowel necrosis from visceral ischemia;
- Participation in other device/drug trials within 1 year;
- Moribund status: ASA class 5 with <24h life expectancy;
- Refractory shock (SBP <90 mmHg);
- Pregnancy or lactation;
- Active substance abuse.
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
Yan'an Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650051
Zheng Dr. Jia, Ph.D., +8613669776843, jiazhenghappy@163.com
Xunqiang Prof. Liu, M.D.
About this study
Official title: Safety and Efficacy of TEVAR Combined With Long Bare-metal Stents in the Intervention of ATBAD: a Prospective and Cohort Study
The primary objective of this study is to evaluate the safety and efficacy of the TEVAR combined with extended bare-metal stenting (distal landing zone ≥2 cm below renal arteries) in patients with acute complicated type B aortic dissection (ATBAD).
Additionally, to prevent postoperative true lumen hypoperfusion in residual thoracoabdominal aortic dissection (visceral zone, infrarenal aorta, and iliac arteries) and persistent ischemic manifestations in visceral and lower extremity arteries post-endovascular repair, extended bare-metal stents are deployed to maintain adequate distal true lumen patency. This strategy ensures perfusion to visceral branches and lower limbs while preparing for future complete endovascular aortic repair.
Read the detailed description
Stanford type B aortic dissection (TBAD) accounts for 25-40% of all aortic dissections, characterized by acute onset, rapid progression, and high mortality, representing a critical cardiovascular emergency. While thoracic endovascular aortic repair (TEVAR) remains the standard intervention for TBAD, its benefits on true lumen remodeling and false lumen thrombosis are primarily limited to the stent-graft covered segment. Distal to the stent-graft, persistent re-entry tears in thoracoabdominal arteries convert preoperative exit sites into new entry points. Although TEVAR improves true lumen perfusion distal to the stent-graft, remodeling efficacy remains suboptimal, particularly in cases with preoperative true lumen collapse where post-TEVAR true lumen dimensions remain critically compressed by large false lumen volumes. Currently deployed stent-grafts typically measure 15-20 cm in length. Conventional TEVAR requires ≥1.5 cm proximal healthy aortic segment as landing zone to prevent retrograde type A dissection (RTAD) and ensure stability. For patients with inadequate proximal landing zones (<1.5 cm), advanced techniques including branched stent-grafts, fenestrations, and parallel grafting have enabled TEVAR implementation even with ≤0.5 cm landing zones, facilitated by evolving device technologies and operator expertise. The "TEVAR+bare-stent" hybrid approach theoretically enhances aortic remodeling through reduced radial force. However, standard TEVAR typically deploys single stent-grafts at the proximal descending aortic tear. Extended stent-graft coverage beyond celiac axis level risks visceral artery occlusion, making maintenance of distal organ and limb perfusion an enduring challenge. Moreover, residual distal thoracoabdominal dissection carries risks of false lumen aneurysmal degeneration and rupture, particularly >5 years post-TEVAR. Secondary interventions for chronic residual dissections are complicated by intimal calcification from prolonged false lumen hypertension, combined with chronic hypoxia and inflammation that compromise aortic wall integrity. Persistent false lumen expansion and rupture in residual thoracoabdominal dissection are observed in 23-35% of conventional TEVAR cases, particularly affecting young-to-middle-aged patients with suboptimal blood pressure control beyond 5-year follow-up. Technical challenges in secondary visceral branch reconstruction further compromise long-term quality of life. Therefore, post-endovascular true lumen remodeling in thoracoabdominal segments warrants particular attention, as aortic remodeling constitutes a crucial determinant of therapeutic success beyond procedural technique alone.
This study aims to validate the feasibility and safety of proximal stent-graft plus extended distal bare-metal stenting in thoracoabdominal aorta, compare its efficacy with conventional TEVAR, and characterize its impacts on aortic remodeling and subsequent visceral/distal arterial reconstruction. We anticipate this research will provide critical clinical evidence for managing residual thoracoabdominal dissection after acute TBAD repair.
Using imaging-based analysis and clinical follow-up, this study will compare: (1) conventional TEVAR vs. (2) hybrid proximal stent-graft + extended distal bare-stent strategies in terms of morphological remodeling, adverse events, and long-term outcomes. The findings may elucidate differential impacts on aortic reconstruction and visceral/iliac revascularization, offering evidence-based guidance for managing distal dissection in acute TBAD.
- Conditions
- Aortic Dissection Type B
- Being tested
- Hybrid TEVAR combined with long bare-metal stent intervention
- Keywords
- ATBAD, TEVAR, Extension, Long bare metal scaffolding devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid TEVAR combined with long bare-metal stent interventionDevice
- Primary TEVAR: Primary TEVAR: Employ Carstor® 70-240mm, AnkuraTMⅡ60-200mm, WeFlow-TbranchTM 160-240mm endograft deployed with ≥2cm proximal landing zone coverage.
Concurrent bare-stenting: Post-TEVAR femoral access deployment of Fabulous® (45-150mm) long bare-metal stent with:
Proximal overlap ≥3cm with TEVAR graft. Distal extension 2-6cm below renal artery plane. Maximum distal limit: above iliac bifurcation.
- Intraprocedural angiography with spinal reference mapping guides precise stent positioning relative to visceral arteries and infrarenal aorta.
| Study group | Role | What they receive |
|---|---|---|
| Carstor® 70-240mm, AnkuraTMⅡ60-200mm, WeFlow-TbranchTM and Fabulous® Device Surgical Implant | Experimental | Subjects with acute type B aortic dissection were treated with an endovascular procedure using the Carstor® 70-240mm, AnkuraTMⅡ60-200mm, WeFlow-TbranchTM 160-240mm Thoracic Aortic Endoprosthesis and the Fabulous® 45-150mm long big bare stent via femoral artery access. (Permanent implant) Receives: Device: Hybrid TEVAR combined with long bare-metal stent intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all-cause mortality
30-day all-cause mortality
Measured: 30 days post-intervention
Ratio of increase in aortic true lumen (%)
Ratio of increase in aortic true lumen(%) including three parameters:
- Diameter measurement (unit: mm): The total aortic diameter was obtained based on the 2020 SVS/STS reporting standards, and then the specific values of the true lumen diameter and false lumen diameter were obtained as a percentage of the straight line between the two lumens.
- Area measurement (unit: mm2): The aortic false lumen area = the true and false lumen area - the true lumen area on the same measurement plane.
- The change ratio (%) of true lumen diameter (mm) and area (mm2):
Definition:
Postoperative true lumen diameter increase ratio: (postoperative - preoperative) / preoperative*100% True lumen diameter increase ratio after follow-up: (current follow-up - last follow-up) / last follow-up*100% Postoperative true lumen area increase ratio: (postoperative - preoperative) / preoperative*100% True lumen area increase ratio after follow-up: (current follow-up - last follow-up) / last follow-up area*100%
Measured: 1 month, 6 months, 12 months after surgery
Secondary outcomes (3)
Aortic rupture incidence
Aortic rupture incidence
Measured: 1 month, 6 months, 12 months after surgery
Device-related complications
- endoleak, spinal ischemia, organ failure
- Classification and incidence rates
Measured: 1 month, 6 months, 12 months after surgery
False lumen thrombosis grading
- Complete: No contrast enhancement
- Partial: Partial contrast flow with thrombus
- Patent: Full contrast opacification
Measured: 1 month, 6 months, 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start31 Mar 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic Dissection Type BStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment: All enrolled subjects receive uniform intervention protocol (TEVAR combined with long bare-metal stent intervention)
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan'an Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xunqiang Prof. Liu, M.D., Principal investigator, Yan'an Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892730
- Sponsor's protocol ID
- YAYY-2025-001
- Other IDs
- 82460098
- Acronym
- SAFE-COVER
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rong D, Ge Y, Liu J, Liu X, Guo W. Combined proximal descending aortic endografting plus distal bare metal stenting (PETTICOAT technique) versus conventional proximal descending aortic stent graft repair for complicated type B aortic dissections. Cochrane Database Syst Rev. 2019 Oct 30;2019(10):CD013149. doi: 10.1002/14651858.CD013149.pub2.
PubMed 31684692Fattori R, Montgomery D, Lovato L, Kische S, Di Eusanio M, Ince H, Eagle KA, Isselbacher EM, Nienaber CA. Survival after endovascular therapy in patients with type B aortic dissection: a report from the International Registry of Acute Aortic Dissection (IRAD). JACC Cardiovasc Interv. 2013 Aug;6(8):876-82. doi: 10.1016/j.jcin.2013.05.003.
PubMed 23968705Nienaber CA, Kische S, Zeller T, Rehders TC, Schneider H, Lorenzen B, Bunger C, Ince H. Provisional extension to induce complete attachment after stent-graft placement in type B aortic dissection: the PETTICOAT concept. J Endovasc Ther. 2006 Dec;13(6):738-46. doi: 10.1583/06-1923.1.
PubMed 17154712
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of TEVAR Combined With Long Bare-metal Stents in the Intervention of ATBAD: a Prospective and Cohort Study
- ClinicalTrials.gov ID
- NCT06892730
- Acronym / sponsor ID
- SAFE-COVER / YAYY-2025-001
- Conditions
- Aortic Dissection Type B
- Keywords
- ATBAD, TEVAR, Extension, Long bare metal scaffolding devices
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yan'an Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 25 Mar 2025 (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 primary objective of this study is to evaluate the safety and efficacy of the TEVAR combined with extended bare-metal stenting (distal landing zone ≥2 cm below renal arteries) in patients with acute complicated type B aortic dissection (ATBAD).
Additionally, to prevent postoperative true lumen hypoperfusion in residual thoracoabdominal aortic dissection (visceral zone, infrarenal aorta, and iliac arteries) and persistent ischemic manifestations in visceral and lower extremity arteries post-endovascular repair, extended bare-metal stents are deployed to maintain adequate distal true lumen patency. This strategy ensures perfusion to visceral branches and lower limbs while preparing for future complete endovascular aortic repair.
Detailed description
Stanford type B aortic dissection (TBAD) accounts for 25-40% of all aortic dissections, characterized by acute onset, rapid progression, and high mortality, representing a critical cardiovascular emergency. While thoracic endovascular aortic repair (TEVAR) remains the standard intervention for TBAD, its benefits on true lumen remodeling and false lumen thrombosis are primarily limited to the stent-graft covered segment. Distal to the stent-graft, persistent re-entry tears in thoracoabdominal arteries convert preoperative exit sites into new entry points. Although TEVAR improves true lumen perfusion distal to the stent-graft, remodeling efficacy remains suboptimal, particularly in cases with preoperative true lumen collapse where post-TEVAR true lumen dimensions remain critically compressed by large false lumen volumes. Currently deployed stent-grafts typically measure 15-20 cm in length. Conventional TEVAR requires ≥1.5 cm proximal healthy aortic segment as landing zone to prevent retrograde type A dissection (RTAD) and ensure stability. For patients with inadequate proximal landing zones (<1.5 cm), advanced techniques including branched stent-grafts, fenestrations, and parallel grafting have enabled TEVAR implementation even with ≤0.5 cm landing zones, facilitated by evolving device technologies and operator expertise. The "TEVAR+bare-stent" hybrid approach theoretically enhances aortic remodeling through reduced radial force. However, standard TEVAR typically deploys single stent-grafts at the proximal descending aortic tear. Extended stent-graft coverage beyond celiac axis level risks visceral artery occlusion, making maintenance of distal organ and limb perfusion an enduring challenge. Moreover, residual distal thoracoabdominal dissection carries risks of false lumen aneurysmal degeneration and rupture, particularly >5 years post-TEVAR. Secondary interventions for chronic residual dissections are complicated by intimal calcification from prolonged false lumen hypertension, combined with chronic hypoxia and inflammation that compromise aortic wall integrity. Persistent false lumen expansion and rupture in residual thoracoabdominal dissection are observed in 23-35% of conventional TEVAR cases, particularly affecting young-to-middle-aged patients with suboptimal blood pressure control beyond 5-year follow-up. Technical challenges in secondary visceral branch reconstruction further compromise long-term quality of life. Therefore, post-endovascular true lumen remodeling in thoracoabdominal segments warrants particular attention, as aortic remodeling constitutes a crucial determinant of therapeutic success beyond procedural technique alone.
This study aims to validate the feasibility and safety of proximal stent-graft plus extended distal bare-metal stenting in thoracoabdominal aorta, compare its efficacy with conventional TEVAR, and characterize its impacts on aortic remodeling and subsequent visceral/distal arterial reconstruction. We anticipate this research will provide critical clinical evidence for managing residual thoracoabdominal dissection after acute TBAD repair.
Using imaging-based analysis and clinical follow-up, this study will compare: (1) conventional TEVAR vs. (2) hybrid proximal stent-graft + extended distal bare-stent strategies in terms of morphological remodeling, adverse events, and long-term outcomes. The findings may elucidate differential impacts on aortic reconstruction and visceral/iliac revascularization, offering evidence-based guidance for managing distal dissection in acute TBAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment: All enrolled subjects receive uniform intervention protocol (TEVAR combined with long bare-metal stent intervention)
| Arm | Type | Receives |
|---|---|---|
| Carstor® 70-240mm, AnkuraTMⅡ60-200mm, WeFlow-TbranchTM and Fabulous® Device Surgical Implant | Experimental | Device: Hybrid TEVAR combined with long bare-metal stent interventionSubjects with acute type B aortic dissection were treated with an endovascular procedure using the Carstor® 70-240mm, AnkuraTMⅡ60-200mm, WeFlow-TbranchTM 160-240mm Thoracic Aortic Endoprosthesis and the Fabulous® 45-150mm long big bare stent via femoral artery access. (Permanent implant) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≧18 years old, ≦80 years old;
- Acute phase with a course of disease ≦14 days;
- CTA confirmed diagnosis of active dissection type B in accordance with the Stanford classification in the ESC guidelines, and requiring TEVAR surgery;
- For patients with acute non-type A and non-type B aortic dissection involving the left subclavian artery: current technologies (such as fenestration, single branch, chimney, etc.) can be used to solve the reconstruction of the left subclavian artery;
- The distal end of the dissection exceeds the renal artery plane;
Key exclusion criteria (19 listed)
- Dissection termination above renal arteries;
- Major aortic surgery within 30 days prior (except LSA revascularization);
- Iliofemoral stenosis/angulation precluding endovascular access;
- Non-diagnostic CTA image quality;
- Indeterminate symptom onset time;
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 |
|---|---|---|
| Hybrid TEVAR combined with long bare-metal stent intervention- Primary TEVAR: Primary TEVAR: Employ Carstor® 70-240mm, AnkuraTMⅡ60-200mm, WeFlow-TbranchTM 160-240mm endograft deployed with ≥2cm proximal landing zone coverage. Concurrent bare-stenting: Post-TEVAR femoral access deployment of Fabulous® (45-150mm) long bare-metal stent with: Proximal overlap ≥3cm with TEVAR graft. Distal extension 2-6cm below renal artery plane. Maximum distal limit: above iliac bifurcation. - Intraprocedural angiography with spinal reference mapping guides precise stent positioning relative to visceral arteries and infrarenal aorta. | Device | Carstor® 70-240mm, AnkuraTMⅡ60-200mm, WeFlow-TbranchTM and Fabulous® Device Surgical Implant |
Primary outcome
30-day all-cause mortality
Time frame: 30 days post-intervention
30-day all-cause mortality
Ratio of increase in aortic true lumen (%)
Time frame: 1 month, 6 months, 12 months after surgery
Ratio of increase in aortic true lumen(%) including three parameters: 1. Diameter measurement (unit: mm): The total aortic diameter was obtained based on the 2020 SVS/STS reporting standards, and then the specific values of the true lumen diameter and false lumen diameter were obtained as a percentage of the straight line between the two lumens. 2. Area measurement (unit: mm2): The aortic false lumen area = the true and false lumen area - the true lumen area on the same measurement plane. 3. The change ratio (%) of true lumen diameter (mm) and area (mm2): Definition: Postoperative true lumen diameter increase ratio: (postoperative - preoperative) / preoperative*100% True lumen diameter increase ratio after follow-up: (current follow-up - last follow-up) / last follow-up*100% Postoperative true lumen area increase ratio: (postoperative - preoperative) / preoperative*100% True lumen area increase ratio after follow-up: (current follow-up - last follow-up) / last follow-up area*100%
3 secondary outcomes
Aortic rupture incidence
Time frame: 1 month, 6 months, 12 months after surgery
Device-related complications
Time frame: 1 month, 6 months, 12 months after surgery
False lumen thrombosis grading
Time frame: 1 month, 6 months, 12 months after surgery
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 25 Mar 2025.
- Results publication: PubMed 31684692Rong D, Ge Y, Liu J, Liu X, Guo W. Combined proximal descending aortic endografting plus distal bare metal stenting (PETTICOAT technique) versus conventional proximal descending aortic stent graft repair for complicated type B aortic dissections. Cochrane Database Syst Rev. 2019 Oct 30;2019(10):CD013149. doi: 10.1002/14651858.CD013149.pub2.
- Results publication: PubMed 23968705Fattori R, Montgomery D, Lovato L, Kische S, Di Eusanio M, Ince H, Eagle KA, Isselbacher EM, Nienaber CA. Survival after endovascular therapy in patients with type B aortic dissection: a report from the International Registry of Acute Aortic Dissection (IRAD). JACC Cardiovasc Interv. 2013 Aug;6(8):876-82. doi: 10.1016/j.jcin.2013.05.003.
- Results publication: PubMed 17154712Nienaber CA, Kische S, Zeller T, Rehders TC, Schneider H, Lorenzen B, Bunger C, Ince H. Provisional extension to induce complete attachment after stent-graft placement in type B aortic dissection: the PETTICOAT concept. J Endovasc Ther. 2006 Dec;13(6):738-46. doi: 10.1583/06-1923.1.
- 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.
Xunqiang Prof. Liu, M.D. principal investigator
Yan'an Affiliated Hospital of Kunming Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid TEVAR combined with long bare-metal stent intervention in people with Aortic Dissection Type B, run by Yan'an Affiliated Hospital of Kunming Medical University 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 19 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: opening soon, as of the sponsor's last update on 25 Mar 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 Xunqiang Prof. Liu, M.D. (+8613888390126, liuxunqiang1001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day all-cause mortality (time frame: 30 days post-intervention). 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 NCT06892730, which also lists 3 linked publications.
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 25 Mar 2025.