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

NCT ID: NCT05965271

Last Updated: 2023-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-01-31

Brief Summary

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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

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

Conditions

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Aortic Dissection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Fabulous Thoracic Aortic Stent System

Fabulous Thoracic Aortic Stent System

Intervention Type DEVICE

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

Interventions

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Fabulous Thoracic Aortic Stent System

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hangzhou Endonom Medtech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital Of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

Wuhan Asia General Hospital

Wuhan, Hubei, China

Site Status

Central Hospital of Dalian University of Technology

Dalian, Liaoning, China

Site Status

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Site Status

Beijing Anzhen Hospital, Capital Medical University

Beijing, , China

Site Status

Fu Weiguo

Shanghai, , China

Site Status

Shanghai Chest Hospital

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Weiguo Fu, Professor

Role: CONTACT

13801760929

Facility Contacts

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Baodong Xie

Role: primary

Zhendong Hua

Role: primary

Xijing Zhuang

Role: primary

Kunmei Gong

Role: primary

Xi Guo

Role: primary

Weiguo Fu

Role: primary

Dan Zhu

Role: primary

Other Identifiers

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Fabulous WQ-F02

Identifier Type: -

Identifier Source: org_study_id

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