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

NCT05883592 | Unknown

• 1 other identifier: Fabulous WQ-F01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Aortic Dissection

Keywords

Stent Graft

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Splanchnic arteries perfusion

  3 months, 6 months,12 months after operation

• Incidence of distal new entry

  3 months, 6 months,12 months after operation

• Tortuosity of the descending thoracic aorta

  3 months, 6 months,12 months after operation

• Immediate technical success

  Immediate during surgery

• Incidence of type I and III endoleak

  Immediate during surgery,3 months, 6 months,12 months after operation

Study Arms (1)

Fabulous Thoracic Aortic Stent System

Device: Fabulous Thoracic Aortic Stent System

Interventions

Fabulous Thoracic Aortic Stent System DEVICE

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

Fabulous Thoracic Aortic Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Endonom Medtech Co., Ltd.: lead

Study Sites (2)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Central Study Contacts

Xi Guo

CONTACT

13911048625; happyfred2008@163.com

Xi Guo

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 1, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)