Real-world Study on Fenestrated Stent for Thoracic Aortic Dissection

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"

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 Overview

• Status: Active, not recruiting
• Conditions: Thoracic Aortic Dissection; Thoracic Aortic Disease
• Intervention / Treatment: Device: TALOS

• Study Type: Observational
• Enrollment (Actual): 320

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200020
      • Shanghai Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

a group with Thoracic Aortic Dissection

Description

Inclusion Criteria:

1. Patients scheduled for or already receiving the Talos stent;
2. Age ≥18 years, any gender, non-pregnant or non-lactating;
3. Diagnosed with aortic dissection;
4. Presence of a ≥15mm effective proximal landing zone;
5. Having eligible access artery anatomy;
6. Expected survival >1 year;
7. Capable of understanding the trial purpose, voluntarily participating, signing informed consent, and willing to undergo follow-up.

Exclusion Criteria

1. Definitive diagnosis of aortic-related connective tissue disorders (e.g., Marfan syndrome);
2. Subjects with infectious aortic dissection;
3. Documented allergy to nitinol alloys, contrast agents, or related materials;
4. Severe hepatic/renal dysfunction (ALT or AST >2.5×ULN, serum creatinine >2×ULN);
5. Uncontrolled severe infections (e.g., bacteremia or septicemia);
6. History of active bleeding, coagulopathy, or refusal of blood transfusion;
7. Malignancy with life expectancy <1 year;
8. Pregnancy, lactation, or planned pregnancy during the trial;
9. Concurrent participation in other drug/device trials without completing primary endpoints;
10. Poor compliance with anticipated inability to complete follow-up;
11. Other investigator-determined contraindications for endovascular therapy (e.g., unsuitable vascular access, non-cooperation).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TALOS USED GROUP; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.		12 months

Collaborators and Investigators

• Sponsor: Qingyou Meng

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: thoracic aortic dissection; Talos; Perforated Stent-Graft
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection; Dissection, Thoracic Aorta
• Other Study ID Numbers: ShanghaiGeneralH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No