A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection

NCT05965271 | Unknown

• 1 other identifier: Fabulous WQ-F02
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 7

Brief Summary

A multicenter, retrospective study to evaluate the real-world efficacy of the Fabulous thoracic aortic stent system in the treatment of Stanford Type B aortic dissection.

Conditions

Aortic Dissection

Keywords

Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• Major adverse events

  Include all-cause death, aortic rupture, retrograde type A aortic dissection, distal stent graft induced new entry, endoleak, myocardial infarction, respiratory failure, renal failure, intestinal necrosis, permanent paraplegia, ischemic stroke, and severe lower limb ischemia.

  within 30 days after operation

Secondary Outcomes (5)

• Immediate technical success

  Immediate during operation

• Change of diameter

  30 days, 3 months,6 months after operation

• Major adverse events

  3 months,6 months after operation

• All-cause death and dissection related death

  3 months,6 months after operation

• The incidence of reintervention

  30 days, 3 months,6 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;
• Subject was diagnosed with Stanford Type B dissection and treated with Fabulous thoracic aortic stent system, including either a covered stent system, a bare stent, or both;
• 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 (7)

The First Affiliated Hospital Of Harbin Medical University

Harbin, Heilongjiang, China

Location

Wuhan Asia General Hospital

Wuhan, Hubei, China

Location

Central Hospital of Dalian University of Technology

Dalian, Liaoning, China

Location

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Location

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

Fu Weiguo

Shanghai, China

Location

Shanghai Chest Hospital

Shanghai, 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

Weiguo Fu, Professor

CONTACT

13801760929; fu.weiguo@zs-hospital.sh.cn

Study Design

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

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: August 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

CN (7)