A Randomized Controlled Comparative Study on Effectiveness of Endovascular Repair Versus Best Medical Therapy for Acute Uncomplicated Type B Aortic Dissection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 436
- 试验地点
- 4
- 主要终点
- All-cause mortality
研究概览
简要总结
The purpose of the study is to conduct a randomized controlled trial comparing best medical therapy (BMT) alone to BMT with thoracic endovascular aortic repair (BMT+TEVAR) for uncomplicated acute type B aortic dissection.
详细描述
Study Design:
This is a prospective, two-arm, parallel-group, single-center, pragmatic, randomized clinical trial.
Population:
The target population comprises all adult patients aged 18 years and older who present with uncomplicated acute type B aortic dissection. The study sample will include 436 subjects of both genders and any race or ethnicity.
Procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participant and investigator/treating physician would be blinded until the day of treament initiation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years, regardless of race or ethnicity;
- •Diagnosed with uncomplicated ABAD, i.e., a primary entry tear distal to left subclavian artery with no evidence of malperfusion, end-organ ischemia, rupture, or intractable pain, and onset of symptoms is ≤30 days prior to enrollment;
- •Patient has been stabilized after the acute event with control of pain and blood pressure using ≤3 intravenous antihypertensive medications;
- •Adequate imaging, e.g., CT with contrast (chest + abdomen+ pelvis) is available prior to enrollment; and
- •Indicates willingness to comply with the study protocol and is able to provide a written informed consent;
- •Meets criteria for inclusion in the National Death Index and Social Security Death Master File.
排除标准
- •Diagnosed with Type A aortic dissection;
- •Evidence of complicated ABAD;
- •Chronic Type B aortic dissection (>6 weeks from onset of symptoms);
- •Unable to be randomized and undergo treatment according to protocol within 30 days of symptom onset;
- •Diagnosed with traumatic dissection or penetrating ulcer;
- •Anatomy is not suitable for TEVAR;
- •Previous descending thoracic or abdominal aortic surgery (open or endovascular);
- •Unsuitable access sites, including infection at access sites;
- •Associated aortic aneurysm (descending aortic diameter ≥5.0 cm);
- •Life expectancy <2 years;
- •Unable or unlikely to comply with BMT;
- •Unable or refuse to comply with follow-up;
- •Intend to participate in another trial within 3 months of enrollment;
- •Pregnant or breast-feeding;
- •Vasculitis or known genetic connective tissue disorder (Marfan's syndrome or Ehlers-Danlos syndrome)
- •Active systemic infection;
- •Chronic kidney disease stage 3-5 (estimated glomerular filtration rate <60 mL/min/1.73m2);
- •Cerebral vascular accident within past 3 months; or
- •Clinically significant gastrointestinal bleeding, major surgery, myocardial infarction, or untreated coagulopathy within past 6 weeks.
结局指标
主要结局
All-cause mortality
时间窗: 5 years
Participants would be followed for a period of 5 years following initial presentation
次要结局
- Any major morbidity events(5 years)
- Change in Quality of Life assessment(5 years)
研究者
Harleen K Sandhu
Associate Professor, Department of Cardiothoracic and Vascular Surgery
The University of Texas Health Science Center, Houston