Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility, Safety and Performance Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related neurological deficit
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, Safety and Performance trial 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 30 subjects will be enrolled at 1 site in Germany.
The enrollment period will span a minimum of 3 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
- •Informed Consent obtained
- •≥18 years of age or ≤80 years of age (male or female)
- •Subject must have one of the following diagnosed, based on CT angiography, within 0-14 days:
- •Acute DeBakey I dissection or
- •Acute DeBakey 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
- •Institutionalized individualized due to administrative or judicial order
- •Individuals with a dependent relationship to the sponsor or investigator
- •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
- •Aortic arch aneurysm > 45mm in diameter
结局指标
主要结局
Number of participants with treatment-related neurological deficit
时间窗: 12 weeks
The number of patients with neurological complications related to the treatment device
Number of patients with aortic injury associated with the implantation of the device
时间窗: 12 weeks
The number of patients with aortic injury related to the treatment device
Number of participants with treatment-related mortality
时间窗: 12 weeks
The number of patients with mortality related to the treatment device
Aortic arch branch vessel patency
时间窗: 12 weeks
The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device
次要结局
- Number of participants with treatment-related mortality(24 weeks and 12 months)
- Number of patients with aortic injury associated with the implantation of the device(24 weeks and 12 months)
- Number of participants with treatment-related neurological deficit(24 weeks and 12 months)
- Aortic arch branch vessel patency(24 weeks and 12 months)