NCT07268755

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 320 (actual)
• Sponsor: Qingyou Meng · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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: [phone]

Conditions

• Thoracic Aortic Dissection
• Thoracic Aortic Disease

Interventions

Type	Name	Description
DEVICE	TALOS	A Real-World Study on the Effectiveness of the Talos Thoracic Stent Graft System in Thoracic Endovascular Aortic Repair for Aortic Dissection.

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2025-12-08
• Last updated: 2025-12-08

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study