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

Aortic Dissection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05883592
• Other study ID #: Fabulous WQ-F01
• Status: Not yet recruiting
• Start date: May 2023
• Est. completion date: May 2024

Study information

• Verified date: May 2023
• Source: Hangzhou Endonom Medtech Co., Ltd.
• Contact: Xi Guo
• Phone: 13911048625
• Email: happyfred2008[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Dissection

Intervention

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

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Endonom Medtech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of diameter	The changes of true lumen, false lumen and total aortic diameter before and after surgery in the level of pulmonary artery bifurcation/left atrial (L1), the distal end of covered stent (L2), superior mesenteric artery (L3) and abdominal aortic bifurcation (L4) were recorded.	3 months, 6 months,12 months after operation
Primary	Changes of cross-sectional area	The changes of true lumen, false lumen and total aortic cross-sectional area before and after surgery in the level of pulmonary artery bifurcation/left atrial (L1), the distal end of covered stent (L2), superior mesenteric artery (L3) and abdominal aortic bifurcation (L4) were recorded.	3 months, 6 months,12 months after operation
Primary	Volumetric change	The volumes of the true lumen and false lumen of the aorta before and after surgery were measured from the covered stent placement segment, the proximal end of the bare stent to the level of celiac trunk, from the level of celiac trunk to the level of low kidney, and from the level of low kidney to the abdominal aorta bifurcation.	3 months, 6 months,12 months after operation
Secondary	Splanchnic arteries perfusion	The change rate of postoperative true lumen diameter of branch artery = (postoperative true lumen diameter - preoperative true lumen diameter)/preoperative true lumen diameter ×100%	3 months, 6 months,12 months after operation
Secondary	Incidence of distal new entry	The number of visceral artery segment tears and infrarenal abdominal aorta segment tears were evaluated.	3 months, 6 months,12 months after operation
Secondary	Tortuosity of the descending thoracic aorta	Tortuosity of the descending thoracic aorta = the length of left subclavian artery to descending aorta of coeliac trunk along the center lumen line/the outer curvature length of left subclavian artery to coeliac trunk	3 months, 6 months,12 months after operation
Secondary	Immediate technical success	Immediate technical success was defined as the stent was successfully delivered to the intended site and released.	Immediate during surgery
Secondary	Incidence of type I and III endoleak		Immediate during surgery,3 months, 6 months,12 months after operation
Secondary	Major adverse events occurring within 30 days after surgery	Refers to all-cause mortality, myocardial infarction, ischemic stroke or respiratory failure occurring within 30 days after surgery. More specifically, myocardial infarction refers to a drastic reduction or complete interruption of the coronary blood supply due to coronary artery disease, resulting in severe and prolonged acute ischemia of the corresponding myocardium, leading to necrosis of cardiomyocytes. Ischemic stroke refers to the end result of necrosis of brain tissue caused by narrowing or occlusion of the arteries supplying blood to the brain or insufficient blood supply to the brain. Respiratory failure is defined as a state resulting in significantly prolonged intubation, tracheotomy, deterioration of lung function, or other fatal outcomes.	within 30 days after operation
Secondary	Incidence of severe adverse events	Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.	3 months, 6 months,12 months after operation