Clinical trial NCT05965271: A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection
Official title: A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortic Dissection
Keywords: Aortic Dissection
Lead sponsor: Hangzhou Endonom Medtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-28
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Stanford type B aortic dissection are treated with Fabulous Thoracic Aortic Stent System in the real world.

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Major adverse events
timeFrame: within 30 days after operation
Secondary outcomes:
measure: Immediate technical success
timeFrame: Immediate during operation
measure: Change of diameter
timeFrame: 30 days, 3 months,6 months after operation
measure: Major adverse events
timeFrame: 3 months,6 months after operation
measure: All-cause death and dissection related death
timeFrame: 3 months,6 months after operation
measure: The incidence of reintervention
timeFrame: 30 days, 3 months,6 months after operation
Other outcomes:
Locations:
city: Harbin
country: China
facility: The First Affiliated Hospital Of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Wuhan Asia General Hospital
state: Hubei
city: Dalian
country: China
facility: Central Hospital of Dalian University of Technology
state: Liaoning
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
city: Shanghai
country: China
facility: Fu Weiguo
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References: