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

Hangzhou Endonom Medtech Co., Ltd.260 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

260

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: * ≥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.

Locations (7)

The First Affiliated Hospital Of Harbin Medical University

Harbin, Heilongjiang, China

Wuhan Asia General Hospital

Wuhan, Hubei, China

Central Hospital of Dalian University of Technology

Dalian, Liaoning, China

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Outcomes

Primary Outcomes

Major adverse events

Include all-cause death, aortic rupture, retrograde type A aortic dissection, distal stent graft induced new entry, endoleak, myocardial infarction, respiratory failure, renal failure, intestinal necrosis, permanent paraplegia, ischemic stroke, and severe lower limb ischemia.

Time frame: within 30 days after operation

Secondary Outcomes

Immediate technical success

Immediate technical success was defined as the stent was successfully delivered to the intended site and released.

Time frame: Immediate during operation

Change of diameter

Changes of minimum diameter of true lumen, maximum diameter of false lumen and maximum total diameter of aorta before and after operation.

Time frame: 30 days, 3 months,6 months after operation

Major adverse events

Time frame: 3 months,6 months after operation

All-cause death and dissection related death

All-cause deaths are defined as death from any cause during the follow-up. Dissection related death refers to death caused by rupture of aortic dissection or endovascular treatment of aortic dissection.

Time frame: 3 months,6 months after operation

The incidence of reintervention

Thoracotomy or secondary intervention due to aortic dissection

Time frame: 30 days, 3 months,6 months after operation

Central Contacts

Weiguo Fu, Professor

CONTACT

13801760929 fu.weiguo@zs-hospital.sh.cn

Data from ClinicalTrials.gov

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