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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Incidence of Major Adverse Events (MAE) Within 30 Days Post-Operation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Patients between 18 and 80 years of age.
- •Diagnosis: Patients with the following thoracic aortic conditions confirmed by imaging (CTA):
- •Thoracic aortic dissection
- •True thoracic aortic aneurysm
- •Thoracic pseudoaneurysm
- •Penetrating aortic ulcer
- •Intramural hematoma
- •Indication for Treatment: Patients requiring supra-aortic branch vessel reconstruction due to rupture, impending rupture, malperfusion syndrome, rapid expansion, uncontrolled pain, aneurysmal dilation, or for prophylactic reasons.
- •Proximal Landing Zone: Patients whose proximal stent landing zone is in Zone 0 of the aortic arch.
- •Aortic Anatomy:
- •Length of ascending aorta >4 cm (from the sinotubular junction to the proximal edge of the brachiocephalic artery).
- •Diameter of ascending aorta between 24 mm and 44 mm.
- •Access Vessel Anatomy:
- •Iliac artery diameter ≥7 mm.
- •Brachiocephalic artery diameter ≤24 mm, and length ≥20 mm.
- •Informed Consent: Patients who have been informed about the nature of the study and agreed to participate by signing the informed consent form.
排除标准
- •Infection: Patients with systemic infections within the last 3 months.
- •Recent Neck Surgery: Patients who underwent neck surgery within the past 3 months.
- •Coronary Involvement: Patients with disease extending to the coronary arteries or aortic valve.
- •Infectious or Autoimmune Diseases: Patients with conditions such as infectious aortic disease, large vessel vasculitis, or Marfan syndrome (or other connective tissue disorders).
- •Severe Vascular Conditions: Patients with severe stenosis, calcification, thrombosis, or tortuosity of the carotid or subclavian arteries.
- •Heart Transplant: Patients who have undergone heart transplantation.
- •Recent Cardiac Events: Patients who had a myocardial infarction or stroke within the last 3 months.
- •Advanced Heart Failure: Patients with New York Heart Association (NYHA) Class IV heart failure.
- •Active Gastrointestinal Conditions: Patients with active peptic ulcer disease or upper gastrointestinal bleeding within the past 3 months.
- •Hematologic Abnormalities:
- •Leukopenia (white blood cell count < 3×10⁹/L)
- •Acute anemia (hemoglobin < 90 g/L)
- •Thrombocytopenia (platelet count < 50×10⁹/L)
- •History of bleeding disorders or coagulopathy.
- •Renal Function: Patients with impaired renal function (creatinine > 265 µmol/L) or those with end-stage renal disease.
- •Pregnancy or Lactation: Pregnant or breastfeeding women.
- •Allergy to Contrast Media: Patients with an allergy to the contrast agents used in imaging.
- •Life Expectancy: Patients with an expected survival of less than 12 months.
- •Concurrent Research Participation: Patients involved in other drug or device trials.
- •Other Medical Conditions: Any other disease or condition that, in the opinion of the investigator, may interfere with the endovascular treatment or the patient's ability to participate in the study.
结局指标
主要结局
Incidence of Major Adverse Events (MAE) Within 30 Days Post-Operation
时间窗: 30 days post-operation
This primary outcome measure evaluates the safety of the Quick Yielding Modified (QYM) technique by assessing the incidence of major adverse events (MAE) occurring within 30 days following the surgical intervention. Major adverse events include any significant complications that could impact patient health and recovery, such as stroke, myocardial infarction, aortic rupture, organ failure, or death. The goal is to determine the short-term safety profile of the intervention, providing critical information on its clinical viability for patients with complex aortic arch diseases. Data will be collected through patient monitoring, clinical assessments, and medical records during the specified follow-up period.
次要结局
- Aortic Treatment Success Rate at 12 Months(Up to 12 months post-operation)
- All-Cause Mortality(Up to 12 months post-operation)
- Aortic-Related Mortality(Up to 12 months post-operation)
- Incidence of Severe Adverse Events(Up to 12 months post-operation)
- Occurrence of Type I or III Endoleaks(Up to 12 months post-operation)
- Rate of Stent Graft Migration(Up to 12 months post-operation)
- Patency Rate of Revascularized Branch Vessels(Up to 12 months post-operation)
- Rate of Conversion to Open Surgery or Reintervention Due to Aortic Complications(Up to 12 months post-operation)
- Incidence of Major Adverse Events (MAE) at 12 Months(12 months post-operation)
- Freedom from Aortic Rupture(12 months post-operation)
- Freedom from Reintervention(12 months post-operation)
研究者
Qingwei Ding
Medical Doctor, Sub-PI
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine