Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2025-12-24 @ 1:56 PM
NCT ID:
NCT07198295
Brief Summary:
This multicenter, prospective, observational study aims to evaluate the efficacy and safety of thoracic endovascular aortic repair (TEVAR) combined with false lumen embolization using vascular plugs in patients with acute type B aortic dissection. Despite TEVAR being a standard treatment for type B dissection, long-term outcomes remain suboptimal due to persistent false lumen perfusion through distal re-entry tears, leading to aortic expansion and high reintervention rates. This study addresses the clinical need for a more definitive treatment strategy that promotes complete false lumen thrombosis and aortic remodeling.
The study plans to enroll 72 subjects across multiple centers in China, with each participant followed for 12 months. Key inclusion criteria comprise patients with acute or subacute (≤30 days from onset) type B aortic dissection exhibiting typical symptoms and extending to the infrarenal aorta, who are scheduled for the combined procedure. Exclusion criteria included those requiring emergency surgery, complicated dissections with malperfusion or rupture, trauma-related or infectious etiologies, prior aortic surgery, uncontrolled systemic diseases, recent myocardial infarction or stroke, and patients outside the 18-80 age range or refusing participation.
The primary efficacy endpoint is the complete thrombosis rate of the false lumen in the thoracic aorta at 12 months postoperatively, while the primary safety endpoint is the incidence of major adverse events (MAEs) at the same time point. MAEs are defined as a composite of all-cause mortality, myocardial infarction, respiratory failure requiring prolonged ventilation or reintubation, renal deterioration (\>50% reduction in eGFR or new dialysis), bowel ischemia requiring surgery or refractory to medical therapy, major stroke, and grade 3 paraplegia. Secondary endpoints include thrombosis rates at 1 and 6 months in the thoracic aorta, patency and thrombosis status at the celiac trunk and infrarenal aortic levels at 1, 6, and 12 months, incidence of MAEs at earlier timepoints, and rates of endoleaks and reinterventions.
All subjects will receive a standardized treatment protocol involving TEVAR with stent-graft placement to seal the proximal entry tear, followed by selective catheterization of the false lumen and deployment of 1-3 vascular plugs at predetermined locations: one parallel to the distal edge of the thoracic stent-graft, one at the level of the celiac trunk, and one at the distal re-entry tear in the infrarenal aorta. Follow-up assessments are scheduled at 1, 6, and 12 months post-procedure, including clinical evaluation and thoracoabdominal CTA imaging to assess aortic remodeling and complication status.
This investigation represents the first prospective multicenter effort to evaluate the combined TEVAR and false lumen embolization strategy. By addressing the fundamental limitation of conventional TEVAR-incomplete false lumen exclusion-this study may establish a new standard for achieving complete aortic remodeling in type B dissection. The results are anticipated to provide robust evidence for guiding clinical practice and potentially influencing future treatment guidelines in aortic disease management.
Study:
NCT07198295
Study Brief:
Protocol Section:
NCT07198295