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

Aortic Dissection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05965271
• Other study ID #: Fabulous WQ-F02
• Status: Not yet recruiting
• Start date: August 1, 2023
• Est. completion date: January 2024

Study information

• Verified date: August 2023
• Source: Hangzhou Endonom Medtech Co., Ltd.
• Contact: Weiguo Fu, Professor
• Phone: 13801760929
• Email: fu.weiguo[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Dissection

Intervention

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

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing
China	Central Hospital of Dalian University of Technology	Dalian	Liaoning
China	The First Affiliated Hospital Of Harbin Medical University	Harbin	Heilongjiang
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	Fu Weiguo	Shanghai
China	Shanghai Chest Hospital	Shanghai
China	Wuhan Asia General Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Endonom Medtech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 30 days after operation
Secondary	Immediate technical success	Immediate technical success was defined as the stent was successfully delivered to the intended site and released.	Immediate during operation
Secondary	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.	30 days, 3 months,6 months after operation
Secondary	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.	3 months,6 months after operation
Secondary	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.	3 months,6 months after operation
Secondary	The incidence of reintervention	Thoracotomy or secondary intervention due to aortic dissection	30 days, 3 months,6 months after operation