A Real-World Study on Distal Aortic Remodeling for Stanford Type B Aortic Dissection With Fabulous Thoracic Aortic Stent System

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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-31

Study Completion Date

2024-05-31

Brief Summary

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To evaluate aortic remodeling of Fabulous thoracic aortic stent system in the treatment of acute and subacute Stanford type B aortic dissection (the changes of aortic diameter, cross-sectional area,and volume of true lumen, false lumen and total aorta in different aoritc levels, and false lumen thrombosis in different aoritc levels), and splanchnic artery perfusion.

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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

PROSPECTIVE

Study Groups

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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

1. ≥18 years old, regardless of gender;
2. Fabulous thoracic aortic stent System is suitable for the treatment of acute or subacute Stanford type B dissection, and the lesions meet one of the following criteria:

1. It is necessary to treat distal lesions due to the presence of distal tears;
2. The dissection involved a wide range, and there was collapse of the distal true cavity;
3. Dissection combined with poor perfusion of distal branch vessels.
3. With appropriate arterial access and suitable for endovascular aortic repair;
4. 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

1. 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;
2. Patients were unable or unwilling to participate in the study;
3. 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