Thoracic Aortic DissectionNCT07268755
Real-world Study on Fenestrated Stent for Thoracic Aortic Dissection
An observational study of Thoracic Aortic Dissection and Thoracic Aortic Disease, run by Qingyou Meng at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Dissection, Thoracic Aortic Disease
- What is being tested?
- TALOS
- Type of treatment
- Medical device
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 30 Nov 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: a group with Thoracic Aortic Dissection
Who may be able to join
- Patients scheduled for or already receiving the Talos stent;
- Age ≥18 years, any gender, non-pregnant or non-lactating;
- Diagnosed with aortic dissection;
- Presence of a ≥15mm effective proximal landing zone;
- Having eligible access artery anatomy;
- Expected survival >1 year;
- Capable of understanding the trial purpose, voluntarily participating, signing informed consent, and willing to undergo follow-up.
Who cannot join
- Definitive diagnosis of aortic-related connective tissue disorders (e.g., Marfan syndrome);
- Subjects with infectious aortic dissection;
- Documented allergy to nitinol alloys, contrast agents, or related materials;
- Severe hepatic/renal dysfunction (ALT or AST >2.5×ULN, serum creatinine >2×ULN);
- Uncontrolled severe infections (e.g., bacteremia or septicemia);
- History of active bleeding, coagulopathy, or refusal of blood transfusion;
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- Malignancy with life expectancy <1 year;
- Pregnancy, lactation, or planned pregnancy during the trial;
- Concurrent participation in other drug/device trials without completing primary endpoints;
- Poor compliance with anticipated inability to complete follow-up;
- Other investigator-determined contraindications for endovascular therapy (e.g., unsuitable vascular access, non-cooperation).
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200020
About this study
Official title: Multi-center, Real-world Study on the Treatment of Thoracic Aortic Dissection With a Straight-type Fenestrated Covered Stent System for Thoracic Aortic Aneurysms
Study Title:
"Multi-center Real-world Study on Straight Tubular Thoracic Aortic Perforated Stent-Graft System for Treating Thoracic Aortic Dissection"
Read more
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
- Being tested
- TALOS
- Keywords
- thoracic aortic dissection, Talos, Perforated Stent-Graft
- Medical subject headings
- Dissection, Thoracic Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TALOSDevice
A Real-World Study on the Effectiveness of the Talos Thoracic Stent Graft System in Thoracic Endovascular Aortic Repair for Aortic Dissection.
| Study group | Role | What they receive |
|---|---|---|
| TALOS USED GROUP | Population who have received TALOS stents Receives: Device: TALOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Dec 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Aortic DissectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 320 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Qingyou Meng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qingyou Meng, Shanghai General Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268755
- Sponsor's protocol ID
- ShanghaiGeneralH
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Real-world Study on the Treatment of Thoracic Aortic Dissection With a Straight-type Fenestrated Covered Stent System for Thoracic Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT07268755
- Acronym / sponsor ID
- ShanghaiGeneralH
- Keywords
- thoracic aortic dissection, Talos, Perforated Stent-Graft
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Qingyou MengUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 8 Dec 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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TALOS USED GROUP | – | Device: TALOSPopulation who have received TALOS stents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- a group with Thoracic Aortic Dissection
Key inclusion criteria (7 listed)
- Patients scheduled for or already receiving the Talos stent;
- Age ≥18 years, any gender, non-pregnant or non-lactating;
- Diagnosed with aortic dissection;
- Presence of a ≥15mm effective proximal landing zone;
- Having eligible access artery anatomy;
Key exclusion criteria (11 listed)
- Definitive diagnosis of aortic-related connective tissue disorders (e.g., Marfan syndrome);
- Subjects with infectious aortic dissection;
- Documented allergy to nitinol alloys, contrast agents, or related materials;
- Severe hepatic/renal dysfunction (ALT or AST >2.5×ULN, serum creatinine >2×ULN);
- Uncontrolled severe infections (e.g., bacteremia or septicemia);
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 |
|---|---|---|
| TALOSA Real-World Study on the Effectiveness of the Talos Thoracic Stent Graft System in Thoracic Endovascular Aortic Repair for Aortic Dissection. | Device | TALOS USED GROUP |
Primary outcome
Treatment success rate at 12 months post-procedure
Time frame: 12 months
Defined as immediate technical success after the procedure and no reintervention required during the 12-month follow-up period.
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
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 8 Dec 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Aortic Dissection and Thoracic Aortic Disease, run by Qingyou Meng 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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 8 Dec 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?
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?
Treatment success rate at 12 months post-procedure (time frame: 12 months). 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 8 Dec 2025.