A Real-World Study on Distal Aortic Remodeling for Stanford Type B Aortic Dissection With Fabulous Thoracic Aortic Stent System

Hangzhou Endonom Medtech

Status: Not yet enrolling

Conditions: Aortic Dissection

Treatments: Device: Fabulous Thoracic Aortic Stent System

Study type: Observational

Funder types: Industry

Identifiers

NCT05883592

Fabulous WQ-F01

Details and patient eligibility

About

To evaluate aortic remodeling of Fabulous thoracic aortic stent system in the treatment of acute and subacute Stanford type B aortic dissection (the changes of aortic diameter, cross-sectional area,and volume of true lumen, false lumen and total aorta in different aoritc levels, and false lumen thrombosis in different aoritc levels), and splanchnic artery perfusion.

Full description

Fabulous Thoracic Aortic Stent System is specially designed for aortic dissection based on PETTICOAT technique.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥18 years old, regardless of gender;

2. Fabulous thoracic aortic stent System is suitable for the treatment of acute or subacute Stanford type B dissection, and the lesions meet one of the following criteria:

   1. It is necessary to treat distal lesions due to the presence of distal tears;
   2. The dissection involved a wide range, and there was collapse of the distal true cavity;
   3. Dissection combined with poor perfusion of distal branch vessels.

3. With appropriate arterial access and suitable for endovascular aortic repair;

4. Subjects could understand the purpose of the trial, volunteered to participate in the study, signed the informed consent form by themselves or their legal representatives, and were willing to complete the follow-up as required by the protocol.

Exclusion criteria

1. Patients have participated in clinical trials of other drugs or medical devices related to target lesion treatment or have participated in clinical trials of other drugs or medical devices and have not reached the primary endpoint;
2. Patients were unable or unwilling to participate in the study;
3. Patients were judged by the investigator to be ineligible for participation in the trial.

Trial design

50 participants in 1 patient group

Fabulous Thoracic Aortic Stent System

Treatment:

Device: Fabulous Thoracic Aortic Stent System