Status:
UNKNOWN
A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection
Lead Sponsor:
Hangzhou Endonom Medtech Co., Ltd.
Conditions:
Aortic Dissection
Eligibility:
All Genders
18+ years
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
- ≥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
- 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.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT05965271
Start Date
August 1 2023
End Date
January 1 2024
Last Update
August 3 2023
Active Locations (7)
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1
The First Affiliated Hospital Of Harbin Medical University
Harbin, Heilongjiang, China
2
Wuhan Asia General Hospital
Wuhan, Hubei, China
3
Central Hospital of Dalian University of Technology
Dalian, Liaoning, China
4
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China