Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Number of participants with neurological complications (TIA, stroke)
研究概览
简要总结
The objective of this study is to investigate the feasibility and clinical benefits of the AMDS to treat patients with acute DeBakey type I dissections and/or intramural hematomas (IMH) involving the ascending aorta and aortic arch through open surgical repair.
详细描述
AMDS is designed to complement the replacement of the ascending aorta with conventional surgical technique utilizing a conventional polyester graft. AMDS is constructed of an uncovered Nitinol wire braided stent attached proximally to a polytetrafluoroethylene (PTFE) felt graft component. The PFTE felt graft component excludes the FL at the distal aortic anastomosis and the wire stent re-expands the dissection flap within the arch and descending aorta, which aims to treat malperfusion and promote positive remodeling of the aorta.
The DARTS I Feasibility study is a prospective, non-randomized, non-blinded, single-arm, multi-institutional Canadian study evaluating the feasibility and safety of the AMDS graft. A goal of 40 subjects will be enrolled at approximately 5 sites in Canada.
The enrollment period will span a minimum of 12 months from Institutional Review Board (IRB) approval and site activation. Candidates for this study are adults who require repair of an acute DeBakey type I aorta dissection and/or intramural hematoma (IMH). Patients will be consented pre-operatively and enrolled patients will be followed for approximately 5 years after their AMDS implantation date. Data will be collected at 10 time points: baseline (pre-operatively), discharge, 1 month post-operatively, 3 months post-operatively, and 6 months post-operatively, 1 year post-operatively and thereafter, annually, for a total of 5 years.
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
- •Subject must have one of the following diagnosed, based on CT angiography, within 0-14 days:
- •Acute DeBakey type I dissection or
- •Acute DeBakey type I intramural hematoma (IMH)
排除标准
- •General Exclusion Criteria
- •Patients must be excluded from the study if any of the following conditions are true:
- •Less than 18 years of age or over 80 years of age
- •Life expectancy less than 2 years
- •Pregnant or breastfeeding or planning on becoming pregnant within 60 months
- •Unwilling to comply with the follow-up schedule
- •Refusal to give informed consent
- •Medical Exclusion Criteria
- •Patients must be excluded from the study if any of the following conditions are true:
- •Uncontrolled systemic infection
- •Uncontrollable anaphylaxis to iodinated contrast
- •Known allergy(ies) to Nitinol and/or PTFE
- •Patient in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR)
- •Inability to obtain CT angiograms for follow-up
- •Previously diagnosed with Marfan syndrome, Loeys- Dietz syndrome or Ehlers- Danlos syndrome with confirmed laboratory genetic testing on a date prior to the diagnosis of the dissection
- •Anatomical Exclusion Criteria
- •Any pathology of mycotic origin
- •Subacute or chronic dissection of the ascending aorta and aortic arch (>14 days after the index event)
- •Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
- •Extensive thrombus or calcifications in the aortic arch as defined by CT angiography
- •Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography
- •Descending thoracic aneurysm involving the proximal third (1/3) of the descending aorta and measuring > 45mm in diameter.
结局指标
主要结局
Number of participants with neurological complications (TIA, stroke)
时间窗: Late (6 months)
The number of patients with neurological complications related to the treatment device
Number of participants with device-related mortality
时间窗: Late (6 months)
The number of patients with mortality related to the treatment device
次要结局
- Successful reattachment of the intimal flap within the arch(Annually, through study completion, an average of 5 years)
- Thrombosis of the false lumen within the confines of the device(Annually, through study completion, an average of 5 years)
- Assess need for stent removal(Annually, through study completion, an average of 5 years)
- Successful device deployment, and radiographic evidence of false lumen exclusion within the confines of the device(Annually, through study completion, an average of 5 years)