An observational study in Thoracic Aortic Dissection and Thoracic Aortic Disease, sponsored by Qingyou Meng. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Qingyou Meng · Observational
Study Title:
"Multi-center Real-world Study on Straight Tubular Thoracic Aortic Perforated Stent-Graft System for Treating Thoracic Aortic Dissection"
Purpose:
This study aims to evaluate the effectiveness of the Talos stent-graft system, a new device designed to treat aortic dissection (a life-threatening condition where the inner layer of the aorta tears). The stent has unique features like perforations and tapered design to reduce complications compared to traditional stents.
Key Features of the Talos Stent:
Longer length to cover more of the damaged aorta Perforated design at the distal end to improve blood flow Tapered shape to better match natural aortic anatomy Potentially reduces risks like new tears or spinal cord ischemia
Study Details:
Type: Real-world study (combining prospective and retrospective data) Duration: 3 years (2024-2027) Participants: 320 patients across 5 major hospitals in Shanghai Follow-up: Regular check-ups at 1, 3, 6, 12, and 24 months post-surgery Who Can Participate?
Patients may qualify if they:
Are ≥18 years old Have aortic dissection requiring treatment Have suitable blood vessels for stent placement Can commit to follow-up visits Who Cannot Participate?
Patients with:
Connective tissue disorders (e.g., Marfan syndrome) Active infections or cancer with limited life expectancy Severe allergies to stent materials/contrast dye Pregnancy or planning pregnancy What Does Participation Involve? Pre-Surgery: Physical exams, blood tests, CT scans Surgery: Minimally invasive stent placement via groin artery Post-Surgery: Blood pressure management, antiplatelet medication (e.g., aspirin) Follow-up: CT scans and quality-of-life questionnaires
Potential Benefits:
Improved aortic healing Reduced need for repeat surgeries Better quality of life (measured by VascuQoL questionnaire)
Possible Risks:
Standard stent risks (bleeding, infection, allergic reactions) Device-related complications (leaks, migration, new tears) Organ ischemia (reduced blood flow to kidneys/other organs)
Safety Monitoring:
Independent review of all CT scans 24/7 access to vascular specialists Immediate reporting of any complications
Ethical Protections:
Approved by ethics committees at all hospitals Voluntary participation with signed consent Right to withdraw anytime without affecting care
For Healthcare Providers:
This investigator-initiated study (IIS) is funded by Shanghai Science \& Technology Commission. It uses standardized protocols across centers with electronic data capture (EDC) for consistency. The primary endpoint is 12-month treatment success (defined as technical success + no reintervention). Secondary endpoints include aortic remodeling rates and complication profiles.
Contact Information:
Principal Investigator: Dr. Meng Qingyou Institution: Shanghai General Hospital Phone: +86-133-0621-1019
30 studies on the registry are indexed under Dissection, Thoracic Aorta; 10 are open to participants now.
This study's enrollment of 320 is above the median of 102 across 17 observational studies indexed under Dissection, Thoracic Aorta.
Browse Dissection, Thoracic Aorta studies →This is the only study on the registry with Qingyou Meng as lead sponsor.
Counted across the registry records on this site, refreshed daily.
a group with Thoracic Aortic Dissection
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Population who have received TALOS stents
Device: TALOS
A Real-World Study on the Effectiveness of the Talos Thoracic Stent Graft System in Thoracic Endovascular Aortic Repair for Aortic Dissection.
Treatment success rate at 12 months post-procedure
Defined as immediate technical success after the procedure and no reintervention required during the 12-month follow-up period.
Time frame: 12 months
Treatment success rate at 12 months post-procedure, defined as immediate technical success after the procedure and no reintervention required during the 12-month follow-up period.
Time frame: 12 months
Plan to share: Yes
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Nov 2027, 35 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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