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Conventional TEVAR Versus FABULOUS RCT

ConditionType B Aortic Dissection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

• 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • thoracic endovascular aortic repair

    Procedure/Surgery

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

Treatment groups

392 Participants
are divided into 2 treatment groups
Group A: c-TEVARActive comparator 1 intervention
Group B: FabulousExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
12-month postoperative

Secondary outcomes

1

30-day Composite Major Adverse Events (MAE) Rate

The incidence of composite major adverse events include cardiac complications, pulmonary complications, renal failure, cerebrovascular complications, limb ischemia, bowel ischemia and spinal cord injury

Time frame
30-day postoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: