NCT03090230进行中（未招募）不适用
A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With Traumatic Injury of the Descending Thoracic Aorta
Bolton Medical32 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年4月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 32
- 主要终点
- Mortality post-procedure
研究概览
简要总结
The purpose of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with traumatic injury of the descending thoracic aorta (DTA)
详细描述
This is a prospective, multicenter, non-blinded, non-randomized study of the RelayPro Thoracic Stent-Graft in subjects with traumatic injury of the DTA in subjects who are candidates for endovascular repair.The primary objective of the study is all-cause mortality at 30 days post procedure.
The secondary objectives of the trial will include descriptive analyses of procedural and post-procedural observations through 5 years of follow-up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years
- •Subject must have a traumatic injury of the descending thoracic aorta that occurred no more than 30 days prior to the planned stent implant procedure
- •Proximal and distal landing zones with diameter between 19 mm and 42 mm.
- •Subject must have a proximal attachment zone distal to the left common carotid and a distal attachment zone proximal to the origin of the celiac artery.
- •The length of the attachment zones will depend on the intended stent graft diameter.
- •The proximal attachment zone should be: i. 15 mm for 22 - 28 mm grafts with bare stent (20 mm for RelayPro grafts with non-bare stent). ii. 20 mm for 30 - 46 mm grafts with bare stent (25 mm for RelayPro grafts with non-bare stent).
- •The distal attachment zone should be 20 mm for all Relay Pro grafts.
- •Coverage of the left subclavian artery is permitted. Revascularization of the left subclavian artery may be considered in all cases by the treating physician and, especially, in anatomies where revascularization is determined to be clinically necessary
- •Proximal and distal attachment zones containing a straight segment (non-tapered, non-reverse tapered, defined by <10% diameter change) with lengths equal to or greater than the required attachment length for the intended device.
- •Adequate iliac or femoral artery access for introduction of the RelayPro delivery system. Alternative methods to gain proper access may be utilized (e.g., iliac conduit).
- •Subject willing to comply with the follow-up evaluation schedule.
- •Subject (or Legally Authorized Representative, LAR) agrees to sign an Informed Consent Form prior to treatment
排除标准
- •Significant stenosis, calcification, thrombus, or tortuosity of intended fixation sites that would compromise fixation or seal of the device.
- •Planned coverage of left carotid or celiac arteries; or anatomic variants that may compromise circulation to the carotid, vertebral, or innominate arteries after device placement, and are not amenable to subclavian revascularization
- •Prior endovascular or surgical repair in the DTA. The device may not be placed within any prior endovascular or surgical graft.
- •Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal, aorta requiring repair.
- •Prior abdominal aortic aneurysm repair (endovascular or surgical) that was performed less than 6 months prior to the planned stent implant procedure.
- •Untreatable allergy or sensitivity to contrast media or device components.
- •Known or suspected connective tissue disorder.
- •Blood coagulation disorder or bleeding diathesis for which the treatment cannot be suspended for one week pre- and/or post-repair.
- •Coronary artery disease with unstable angina.
- •Severe congestive heart failure (New York Heart Association functional class IV).
- •Stroke and/or Myocardial Infarction within 3 months of the planned treatment date.
- •Pulmonary disease requiring the routine (daily or nightly) need for oxygen therapy outside the hospital setting.
- •Acute renal failure or chronic renal insufficiency, and not receiving dialysis.
- •Hemodynamically unstable.
- •Active systemic infection and/or mycotic aneurysms.
- •Morbid obesity or other condition that may compromise or prevent the necessary imaging requirements.
- •Injury Severity Score of
- •Less than two-year life expectancy.
- •Current or planned participation in an investigational drug or device study that has not completed primary endpoint evaluation.
- •Currently pregnant or planning to become pregnant during the course of the study.
- •Medical, social, or psychological issues that Investigator believes may interfere with treatment or follow-up.
结局指标
主要结局
Mortality post-procedure
时间窗: 30 days
All-cause mortality at 30 days post-procedure
次要结局
- Aortic rupture(1 month, 6 months, 12 months, and annually through 5 years)
- Stent fractures in the attachment zone(1 month, 6 months, 12 months, and annually through 5 years)
- Successful device delivery and deployment(During Implantation)
- Endoleaks(1 month, 6 months, 12 months, and annually through 5 years)
- Aortic expansion(1 month, 6 months, 12 months, and annually through 5 years)
- Endograft infection(1 month, 6 months, 12 months, and annually through 5 years)
- Loss of stent-graft patency(1 month, 6 months, 12 months, and annually through 5 years)
- Compression of stent-graft(1 month, 6 months, 12 months, and annually through 5 years)
- Incidence of open or endovascular secondary interventions(1 month, 6 months, 12 months, and annually through 5 years)
- Vascular access complications(During the initial implant attempt)
- All-cause mortality(1 month, 6 months, 12 months, and annually through 5 years)
- Erosion and/or extrusion(1 month, 6 months, 12 months, and annually through 5 years)
- Aortic-related death(1 month, 6 months, 12 months, and annually through 5 years)
- Migration(1 month, 6 months, 12 months, and annually through 5 years)
- Major adverse events(1 month, 6 months, 12 months, and annually through 5 years)
研究者
研究点 (32)
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