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

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.

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): 260

Contacts and Locations

• Study Contact: Name: Weiguo Fu, Professor; Phone Number: 13801760929; Email: fu.weiguo@zs-hospital.sh.cn

Study Locations

• China
  • Beijing, China
    • Beijing Anzhen Hospital, Capital Medical University
    • Contact: Xi Guo
  • Shanghai, China
    • Shanghai Chest Hospital
    • Contact: Dan Zhu
  • Shanghai, China
    • Fu Weiguo
    • Contact: Weiguo Fu
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • The First Affiliated Hospital of Harbin Medical University
      • Contact: Baodong Xie
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Asia General Hospital
      • Contact: Zhendong Hua
  • Liaoning
    • Dalian, Liaoning, China
      • Central Hospital of Dalian University of Technology
      • Contact: Xijing Zhuang
  • Yunnan
    • Kunming, Yunnan, China
      • The First People's Hospital of Yunnan Province
      • Contact: Kunmei Gong

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:

• ≥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.

Exclusion Criteria:

• 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.

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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate technical success	Immediate technical success was defined as the stent was successfully delivered to the intended site and released.	Immediate during operation
Change of diameter	Changes of minimum diameter of true lumen, maximum diameter of false lumen and maximum total diameter of aorta before and after operation.	30 days, 3 months,6 months after operation
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.	3 months,6 months after operation
All-cause death and dissection related death	All-cause deaths are defined as death from any cause during the follow-up. Dissection related death refers to death caused by rupture of aortic dissection or endovascular treatment of aortic dissection.	3 months,6 months after operation
The incidence of reintervention	Thoracotomy or secondary intervention due to aortic dissection	30 days, 3 months,6 months after operation

Collaborators and Investigators

• Sponsor: Hangzhou Endonom Medtech Co., Ltd.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Aortic Dissection
• 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-F02

Drug and device information, study documents

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