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

China50 participantsStarted 2023-05

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ≥18 years old, regardless of gender;
✓. 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:
✓. It is necessary to treat distal lesions due to the presence of distal tears;
✓. The dissection involved a wide range, and there was collapse of the distal true cavity;
✓. Dissection combined with poor perfusion of distal branch vessels.
✓. 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.

What they're measuring

Change of diameter

Timeframe: 3 months, 6 months,12 months after operation

Changes of cross-sectional area

Timeframe: 3 months, 6 months,12 months after operation

Volumetric change

Timeframe: 3 months, 6 months,12 months after operation

Trial details

NCT IDNCT05883592

SponsorHangzhou Endonom Medtech Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-05

Contact for this trial

Xi Guo

13911048625 happyfred2008@163.com

View on ClinicalTrials.gov More Aortic Dissection trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ≥18 years old, regardless of gender;
✓. 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:
✓. It is necessary to treat distal lesions due to the presence of distal tears;
✓. The dissection involved a wide range, and there was collapse of the distal true cavity;
✓. Dissection combined with poor perfusion of distal branch vessels.
✓. 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.