Conventional TEVAR Versus FABULOUS RCT

NCT06740565 | Not Yet Recruiting

• 1 other identifier: TBAD202412
• Study Type: interventional
• Target: 392
• Locations: 0 countries
• Sites: N/A

Brief Summary

For High-risk Type B aortic dissections, a multicenter, prospective, randomized controlled study is conducted to compare the clinical outcomes of conventional proximal endovascular repair (TEVAR) alone versus the Fabulous system which includes a proximal stent graft with a distal bare metal stent implanted. The study aims to determine the optimal intervention method for such population.

Conditions

Type B Aortic Dissection

Keywords

endovascular repair; distal bare stent

Outcome Measures

Primary Outcomes (1)

• 12-Month Positive Aortic Remodeling Rate

  Definition of Positive Aortic Remodeling (meeting at least one of the following criteria). Reduction in the maximum diameter or volume of the false lumen with total aortic diameter or volume growth of less than 5mm or reduction. Increase in the maximum diameter or volume of the true lumen with total aortic diameter or volume growth of less than 5mm or reduction. Reduction in the maximum aortic diameter (with corresponding changes in both true and false lumen diameters).

  12-month postoperative

Secondary Outcomes (1)

• 30-day Composite Major Adverse Events (MAE) Rate

  30-day postoperative

Study Arms (2)

c-TEVAR

ACTIVE COMPARATOR

conventional thoracic endovascular aortic repair

Procedure: thoracic endovascular aortic repair

Fabulous

EXPERIMENTAL

proximal stent graft combined with distal bare stent

Procedure: thoracic endovascular aortic repair

Interventions

thoracic endovascular aortic repair PROCEDURE

stent-graft implanted to seal the proximal entry tear of type B aortic dissection

Fabulous; c-TEVAR

Eligibility Criteria

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

You may qualify if:

• Males aged 18 years or older, or non-pregnant females
• Diagnosed with high-risk Type B aortic dissection with a narrow true lumen (defined as the minimum true lumen diameter being less than 30% of the total vessel diameter) and/or poor radiographic or clinical visceral perfusion (including abnormal blood supply to the liver, kidneys, mesentery, or lower limb ischemia)
• Deemed suitable for endovascular treatment according to the investigator's judgment
• Able to understand the purpose of the trial, willing to participate voluntarily and sign the informed consent form, and committed to follow-up visits.

You may not qualify if:

• Subjects with hemodynamic instability or ruptured aortic dissection
• Subjects who, due to various anatomical factors, are unable to undergo TEVAR alone
• Subjects with connective tissue diseases, such as Marfan syndrome
• Subjects in poor general condition, unable to tolerate general anesthesia
• Subjects allergic to contrast agents, nitinol stent materials, or other stent components
• Subjects with a life expectancy of less than 12 months
• Subjects with a history of myocardial infarction or unstable angina within the past 3 months
• Subjects with a history of TIA or cerebral infarction within the past 3 months
• Subjects with creatinine levels exceeding 2.5 times the upper normal limit or those currently on dialysis
• Subjects with severe conditions such as liver failure

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Interventions

Endovascular Aneurysm Repair

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Central Study Contacts

Yuanqing Kan, MD

CONTACT

0086-13585939248; echok624@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 18, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL