Trials (Aug 2023)
Early endovascular intervention for unfavorable remodeling of the thoracic aorta after open surgery for acute DeBakey type I aortic dissection: study protocol for a multicenter, randomized, controlled trial
Abstract
Abstract Background Total arch replacement with frozen elephant trunk has been developed with promising results for DeBakey type I aortic dissection. However, several problems, such as continuous perfusion of distal false lumen and unfavorable remodeling of distal aorta postoperatively, can seriously affect the long-term outcome. This trial aims to assess the effects of early minimally invasive endovascular repair on distal aortic remodeling and long-term clinical outcomes in patients with dominant false lumen and residual tears in the descending thoracic aorta after total arch replacement and frozen elephant trunk procedure. Methods This is a protocol for a two-arm, parallel, multicenter, randomized controlled trial. A total of 154 eligible patients will be recruited from four hospitals in China and randomized on a 1:1 basis either to the experiment group (endovascular repair in addition to routine antihypertensive therapy) or the control group (routine antihypertensive therapy without early surgical treatment). The primary outcome will be the five-year all-cause mortality. The secondary outcomes will include re-intervention, ischemic symptoms, organ dysfunction, and stent-related adverse events. Discussion If early minimally invasive endovascular repair could safely and effectively promote distal aortic remodeling and bring favorable long-term outcomes for patients with dominant false lumen and residual tears in the descending thoracic aorta after total arch replacement and frozen elephant trunk technique, it would improve the treatment strategy for DeBakey type I aortic dissection. Trial registration Chinese Clinical Trial Registry, CHiCTR2000030050. Registered on 11 March 2020.
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