Clinical trial NCT05883592: A Real-World Study on Distal Aortic Remodeling for Stanford Type B Aortic Dissection With Fabulous Thoracic Aortic Stent System
Official title: A Real-World Study on Distal Aortic Remodeling for Stanford Type B Aortic Dissection With Fabulous Thoracic Aortic Stent System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Dissection
Keywords: Stent Graft
Lead sponsor: Hangzhou Endonom Medtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change of diameter
timeFrame: 3 months, 6 months,12 months after operation
measure: Changes of cross-sectional area
timeFrame: 3 months, 6 months,12 months after operation
measure: Volumetric change
timeFrame: 3 months, 6 months,12 months after operation
Secondary outcomes:
measure: Splanchnic arteries perfusion
timeFrame: 3 months, 6 months,12 months after operation
measure: Incidence of distal new entry
timeFrame: 3 months, 6 months,12 months after operation
measure: Tortuosity of the descending thoracic aorta
timeFrame: 3 months, 6 months,12 months after operation
measure: Immediate technical success
timeFrame: Immediate during surgery
measure: Incidence of type I and III endoleak
timeFrame: Immediate during surgery,3 months, 6 months,12 months after operation
measure: Major adverse events occurring within 30 days after surgery
timeFrame: within 30 days after operation
measure: Incidence of severe adverse events
timeFrame: 3 months, 6 months,12 months after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
Study officials:
References: