NCT05174767进行中（未招募）不适用
A ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection: PERSEVERE
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 115
- 试验地点
- 25
- 主要终点
- Primary Endpoint to Assess Incidence of Major Adverse Events
研究概览
简要总结
Prospective, non-randomized, multicenter clinical investigation to assess the safety and effectiveness of AMDS in the treatment of patients with acute DeBakey type I dissection, with evidence of malperfusion, through open surgical repair.
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
- •≥18 years of age or ≤80 years of age (male or female) at time of surgery
- •Acute DeBakey type I dissection based on computed tomography angiography (CTA) and diagnosed ≤14 days from of the index event
- •Presence of malperfusion (cerebral, visceral, renal, spinal cord, and/or peripheral)
排除标准
- •Other medical condition that is associated with limited life expectancy <2 years (e.g., cancer, congestive heart failure)
- •Pregnant or breastfeeding.
- •Unwilling to comply with the follow-up schedule
- •Institutionalized due to administrative or judicial order
- •Unwilling to accept blood transfusions for any reason
- •Coronary malperfusion
- •In circulatory shock (i.e., systolic blood pressure <90 mmHg) at time of screening
- •In extreme hemodynamic compromise requiring cardiopulmonary resuscitation at time of screening
- •Suspicion of bowel necrosis (as determined by the implanting physician based on imaging observations, peritoneal signs, surgical exploration, elevated serum lactate levels, low pH, and/or acidosis)
- •Clinical or radiographic signs of bowel infarction or gastrointestinal hemorrhage
- •Base deficit > -10 mmol/L or -10 mEq/L
- •American Society of Anesthesiologists risk class V (i.e., moribund patient not expected to live 24 hours with or without operation) or class VI (a declared brain dead patient whose organs are being removed for donor purposes)
- •Previous placement of a thoracic endovascular graft
- •Interventional and/or open surgical procedures 30 days prior to the dissection repair
- •Planned major interventional and/or open surgical procedures 30 days post the dissection repair
- •Systemic infection
- •Uncontrollable anaphylaxis to iodinated contrast (patients with allergy to iodinated contrast but not anaphylaxis may be eligible with appropriate pre-medication, as deemed suitable by the Investigator)
- •Known allergy(ies) to nitinol and/or polytetrafluoroethylene
- •Inability to obtain CT angiograms for follow-up
- •Previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, or Loeys-Dietz syndrome based on laboratory genetic testing
- •Diagnosed with acute myocardial infarction in the 30 days prior to the dissection diagnosis
- •Diagnosed with severe and catastrophic neurological complications in the 30 days prior to the dissection diagnosis (namely, obtundation or coma)
- •Current Stage 5 end stage chronic kidney disease (eGFR ≤ 15 mL/min)
- •History of bleeding disorder (i.e. hemophilia)
- •A primary entry tear that extends into the arch or distal to the left subclavian artery
- •Need for a total aortic arch replacement and/or repair, or reconstruction, of any part of the arch, and branch vessels (including extra-anatomic bypass of the branch vessels), for any reason as deemed necessary by the Investigator
- •Any pathology of mycotic origin
- •Aortic fistulous communication with non-vascular structure (e.g., esophagus, bronchial)
- •Extensive thrombus or calcifications in the aortic arch, as defined by CTA
- •Excessive tortuosity precluding safe passage of the AMDS, as defined by CTA
- •Descending thoracic aneurysm involving the proximal third (one-third) of the descending aorta and measuring >45 mm in diameter
- •Aortic arch aneurysm >50 mm in diameter
研究组 & 干预措施
Acute DeBakey Type I Dissection
Experimental
In eligible patients, the ascending aorta is transected and removed in a routine standard of care manner utilizing hypothermic circulatory arrest; the operator will leave at least 10 mm (1.0 cm) aortic tissue proximal to the innominate artery. AMDS is pre-loaded onto the delivery system and is delivered into the true lumen through the open distal aorta and implanted according to the instructions for use.
干预措施: AMDS (Device)
结局指标
主要结局
Primary Endpoint to Assess Incidence of Major Adverse Events
时间窗: Through 30 days
Patients experiencing at least one of the following MAEs: 1. All-cause mortality (ACM) 2. New disabling stroke 3. New onset renal failure requiring dialysis 4. Myocardial infarction (MI)
Primary Endpoint to Assess Distal Anastomotic New Entry (DANE) tears
时间窗: Through 30 days
Patients experiencing Distal Anastomotic New Entry (DANE) tears
次要结局
未报告次要终点
研究者
研究点 (25)
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