Quick Yielding Modified Short-Distance Fenestration Technique for the Treatment of Complex Aortic Arch Diseases: a Multicenter Single-Arm Objective Performance Criteria Trial(QYM-Tech Study)

This secondary outcome measure assesses the effectiveness of the Quick Yielding Modified (QYM) technique by evaluating the rate of successful treatment of the aortic condition at 12 months post-intervention. Treatment success is defined as the absence of significant complications, such as re-intervention or aortic-related adverse events, and the proper functioning of the thoracic stent graft with no significant endoleaks. This measure provides insight into the long-term effectiveness and durability of the surgical intervention.

This secondary outcome measure records the rate of all-cause mortality among participants within the study period, allowing for an evaluation of overall patient survival following the intervention. It provides crucial data on the safety and effectiveness of the QYM technique in comparison to the underlying risk of mortality associated with complex aortic arch diseases.

This secondary outcome measure focuses specifically on mortality directly related to aortic conditions or complications arising from the surgical intervention. This measure helps to evaluate the long-term safety of the QYM technique concerning life-threatening aortic issues.

This measure tracks the occurrence of severe adverse events in participants, including complications such as stroke, myocardial infarction, and organ failure that are serious enough to require medical intervention. Monitoring these events provides a broader understanding of the risks associated with the procedure.

This measure evaluates the incidence of Type I or Type III endoleaks following the intervention. Endoleaks are complications that can lead to re-intervention, and monitoring them is critical for assessing the effectiveness of the stent graft placement.

This measure assesses the migration of the thoracic stent graft from its original position within the aorta. Stent migration can affect the success of the procedure and requires careful monitoring to ensure the stent remains securely in place.

This measure evaluates the patency (openness and functionality) of the revascularized supra-aortic branches at follow-up visits. A high patency rate indicates successful reconstruction and blood flow restoration to these vessels.

This measure tracks the incidence of participants who require conversion to open surgery or additional interventions due to complications related to the aorta after the initial procedure. It provides insight into the long-term risks and effectiveness of the QYM technique.

This measure assesses the occurrence of major adverse events (MAE) within the 12-month follow-up period. Major adverse events include complications such as stroke, myocardial infarction, aortic rupture, or death. Monitoring the incidence of these events over the long term provides additional data on the safety and durability of the Quick Yielding Modified (QYM) technique.

This outcome tracks the percentage of participants who remain free from aortic rupture following the QYM technique over the course of 12 months. Aortic rupture is a life-threatening event, and the goal is to assess whether the intervention effectively prevents this complication in patients with complex aortic arch diseases.

This measure evaluates the percentage of participants who do not require additional surgical or endovascular interventions on the thoracic aorta or supra-aortic branches after the initial procedure. The goal is to assess the long-term effectiveness of the QYM technique and its ability to prevent the need for further treatments.