NCT06639243

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)

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)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Background: This study investigates the safety and efficacy of a novel surgical approach combining thoracic endovascular aortic repair (TEVAR) and in situ fenestration reconstruction of supra-aortic branches using the Quick Yielding Modified (QYM) technique. This procedure aims to address complex aortic arch diseases, providing an alternative to more invasive open surgical interventions. Methods: This is a prospective, multicenter, single-arm, interventional study involving 87 patients across 3 centers. Eligible participants are adults aged 18-80 diagnosed with thoracic aortic dissection, thoracic aortic aneurysm (true or pseudo), penetrating aortic ulcer, or intramural hematoma, necessitating supra-aortic branch vessel reconstruction. The surgical protocol involves TEVAR combined with the QYM technique for fenestration and revascularization. Primary Outcome: The primary endpoint is the incidence of major adverse events (MAE) within 30 days post-operation. Secondary Outcomes: Secondary endpoints include 12-month aortic treatment success, all-cause mortality, aortic-related mortality, incidence of severe adverse events, occurrence of Type I/III endoleaks, stent graft migration, patency of revascularized branches, and rates of conversion to open surgery or reintervention due to aortic complications. Inclusion/Exclusion Criteria: Key inclusion criteria include imaging-confirmed thoracic aortic disease requiring endovascular repair with a proximal landing zone in the aortic arch (Zone 0) and suitable anatomical features for stent placement. Patients with recent systemic infections, severe coronary artery involvement, or other significant comorbidities were excluded. Follow-up and Statistical Analysis: Patients will undergo follow-ups at discharge, 30 days, 6 months, and 12 months post-surgery. Statistical analyses will include descriptive statistics of quantitative and categorical variables, with statistical significance set at a one-sided p-value \< 0.025. This study aims to provide critical insights into the clinical applicability of the QYM technique, potentially broadening therapeutic options for complex aortic arch diseases.

Conditions

• Thoracic Aortic Dissection
• Thoracic Aortic Aneurysm (true Aneurysm)
• Thoracic Pseudoaneurysm
• Penetrating Aortic Ulcer
• Intramural Hematoma of the Thoracic Aorta

Interventions

Type	Name	Description
DEVICE	QYM Technique	The intervention in this study involves the application of the Quick Yielding Modified (QYM) technique for the treatment of complex aortic arch diseases. This procedure consists of two main components: 1. Thoracic Endovascular Aortic Repair (TEVAR): This minimally invasive procedure utilizes a covered stent graft to exclude the diseased segment of the thoracic aorta, providing immediate protection against rupture and controlling blood flow. 2. In Situ Fenestration and Revascularization of Supra-Aortic Branches: Following TEVAR, the QYM technique includes creating fenestrations in the stent graft to allow for the revascularization of the supra-aortic branches (such as the brachiocephalic, left common carotid, and left subclavian arteries). This is achieved through direct puncture and reconstruction of the branch vessels, ensuring adequate blood flow to these critical arteries while preserving their function. The combination of these techniques aims to achieve effective treatment out

Timeline

• Start date: 2024-01-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study