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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Dissection
• Intervention / Treatment: Device: Fabulous Thoracic Aortic Stent System

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Xi Guo; Phone Number: 13911048625; Email: happyfred2008@163.com
• Study Contact Backup: Name: Xi Guo

Study Locations

• China
  • Beijing, China
    • Beijing Friendship Hospital, Capital Medical University
  • Beijing
    • Beijing, Beijing, China
      • Beijing Anzhen Hospital, Capital Medical University
      • Contact: Xi Guo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fabulous Thoracic Aortic Stent System	Device: Fabulous Thoracic Aortic Stent System; Endovascular treament in patients with aortic dissection with Fabulous Thoracic Aortic Stent System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Immediate technical success	Immediate technical success was defined as the stent was successfully delivered to the intended site and released.	Immediate during surgery
Incidence of type I and III endoleak		Immediate during surgery,3 months, 6 months,12 months after operation
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
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

Collaborators and Investigators

• Sponsor: Hangzhou Endonom Medtech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Stent Graft
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Dissection
• Other Study ID Numbers: Fabulous WQ-F01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No