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

Hangzhou Endonom Medtech Co., Ltd.50 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Dissection

Interventions

Fabulous Thoracic Aortic Stent SystemDEVICE

Endovascular treament in patients with aortic dissection with Fabulous Thoracic Aortic Stent System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

Change of diameter

The changes of true lumen, false lumen and total aortic diameter before and after surgery in the level of pulmonary artery bifurcation/left atrial (L1), the distal end of covered stent (L2), superior mesenteric artery (L3) and abdominal aortic bifurcation (L4) were recorded.