A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection

Hangzhou Endonom Medtech

Status: Not yet enrolling

Conditions: Aortic Dissection

Treatments: Device: Fabulous Thoracic Aortic Stent System

Study type: Observational

Funder types: Industry

Identifiers

NCT05965271

Fabulous WQ-F02

Details and patient eligibility

About

A multicenter, retrospective study to evaluate the real-world efficacy of the Fabulous thoracic aortic stent system in the treatment of Stanford Type B aortic dissection.

Full description

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

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years old, regardless of gender;
• Subject was diagnosed with Stanford Type B dissection and treated with Fabulous thoracic aortic stent system, including either a covered stent system, a bare stent, or both;
• With appropriate arterial access and suitable for endovascular aortic repair;
• 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

• 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;
• Patients were unable or unwilling to participate in the study;
• Patients were judged by the investigator to be ineligible for participation in the trial.

Trial design

260 participants in 1 patient group

Fabulous Thoracic Aortic Stent System

Treatment:

Device: Fabulous Thoracic Aortic Stent System