NCT00583817Enrolling By Invitation不适用
Endovascular Treatment of Thoracic Aortic Disease
Matthew Eagleton3 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2018年10月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 170
- 试验地点
- 3
- 主要终点
- Stroke and TIA
研究概览
简要总结
The purpose of this study is to assess the role endovascular therapy to treat aortic disease involving the ascending aorta, the aortic arch, and the visceral segment of the aorta (or thoracoabdominal aorta)
详细描述
This study is a prospective, non-randomized, single-site evaluation of the use of novel endovascular technology to treat complex aortic disease.
In an effort to allow for the evaluation of patients with both complex anatomic condition and challenging physiologic situations there are three study subsections as follows:
- Ascending Arm Protocol: The intended use of the study is to provide endovascular therapy to patients with ascending aortic pathology including aneurysm, pseudoaneurysm, and/or aortic dissection who are considered high risk for conventional surgery. This will involve disease in the aorta from the sinotubular junction to the innominate artery.
- Aortic Arch Arm Protocol: The intended use of the study is to provide endovascular therapy to patients with aortic arch pathology including aneurysm, pseudoaneurysm and/or aortic dissection who are considered high risk for conventional surgery. This will involve disease in aorta from the sinotubular junction to descending thoracic aorta.
- Thoracobabdominal Aortic Arm Protocol: The intended use of the study is to provide endovascular therapy to patients with thoracoabdominal aortic pathology including aortic aneurysms, renal aneurysms, and superior mesenteric artery aneurysms. This will involve the aorta from the left carotid artery origin through the iliac artery bifurcation.
In addition, the purpose of the study is also characterized based on the protocol arm that patients are enrolled:
- Ascending Arm Protocol: The purpose of this study is to assess the safety, efficacy, and intermediate (or long-term) rupture free survival rate of high risk surgical patients undergoing endovascular repair of ASCENDING AORTIC pathology including aortic dissection, aortic aneurysm, and/or aortic pseudoaneurysm. The objectives of this arm are as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Ascending Arm Protocol:
- •General Inclusion Criteria (Must meet ALL of the following):
- •Life expectancy greater than 2 years
- •Suitable arterial anatomy
- •Absence of systemic disease or allergy that precludes an endovascular repair
- •Capable of giving informed consent and willingness to comply with follow up schedule
- •Patient is considered high or prohibitive risk for open surgical repair of the ascending aneurysm or dissection
- •Anatomic Inclusion Criteria
- •Have ONE of the following
- •Focal aneurysm in ascending aorta
- •Pseudoaneurysms and/or dissections that are distal to the sinotubular junction.
- •A thoracoabdominal aortic aneurysm ≥ 5.0 cm in women and ≥ 5.5 cm in men
- •Have morphology or growth suggestive of immanent rupture
- •Must meet ALL of the following:
- •Proximal Fixation:
- •>15 mm aortic length distal to a patent coronary artery or coronary artery bypass that are considered patent and necessary for proper cardiac perfusion.
- •Proximal fixation may occur in either native aorta or surgical graft
- •In the setting of the aortic dissection, the proximal fixation must be proximal to the entry tear.
- •In the setting of aortic dissection, true lumen size must be large enough to allow deployment of the device
- •Aortic diameter at the sinotubular junction >20 mm and ≤ 38mm
- •Distal Fixation: a length of distal ascending aorta >5mm proximal to the innominate artery whereby seal and fixation can be achieved (the dissection flap may transcend the arch, but the seal must be achievable within the true lumen of the dissection)
- •Aortic diameter (true lumen diameter in the setting of a dissection) at the innominate artery is ≤ 42mm. If the diameter at the innominate artery is ≥ 38mm the Low Profile version must be used
- •Distance from the ascending aorta to the innominate artery must be >35mm
- •Iliac artery access
- •Iliac anatomy must allow for the delivery of the endograft device which is loaded within an 18F-24F sheath.
- •Conduits to the iliac vessels or aorta may be used if deemed necessary
- •In the setting of an aortic dissection, access into the true lumen throughout the length of the aorta must be obtainable
- •Arch Arm Protocol
- •General Inclusion Criteria (Must meet ALL of the following):
- •Life expectancy greater than 2 years
- •Suitable arterial anatomy
- •Absence of systemic disease or allergy that precludes an endovascular repair
- •Capable of giving informed consent and willingness to comply with follow up schedule
- •Patient is considered high or prohibitive risk for open surgical repair of the ascending aneurysm or dissection
- •Anatomic Inclusion Criteria
- •Must meet ALL of the following:
- •Aneurysm of the ascending aorta or aortic arch/proximal descending thoracic aorta that is >5.5cm or is considered to be at high risk for rupture or dissection given the morphologic characteristics of the aneurysm (or diverticulum).
- •Proximal aortic fixation zone:
- •Native aorta or surgical graft (If surgical graft in ascending aorta, the angulation within the graft must be <90 degrees)
- •Diameter: 20-42mm
- •Proximal neck length ≥10mm
- •Ascending aortic length >50mm
- •Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion
- •Distal aortic fixation zone:
- •Native aorta or surgical graft
- •Diameter: 20-42mm
- •Distal neck length ≥10mm
- •Supra-aortic trunk (brachiocephalic) vessels
- •Although the prosthesis will typically have two branches, modifications to the design will allow for a single branch or three branches. Thus, it is generally planned that at least one extra-anatomic bypass graft will be done in conjunction (or in a staged fashion) with the procedure. The two vessels incorporated into the endograft repair would most commonly be the innominate artery and left carotid artery. However, the innominate artery may be coupled with the left subclavian artery in the setting of a bovine arch whereby the flow to the left carotid would come from a left subclavian to carotid bypass. Similarly, the left carotid and subclavian artery may be branched, or simply one vessel branched should specific anatomic limitations exist. In such a situation, multiple extra-anatomic bypasses may be necessary. Thus the inclusion criteria are defined for each artery, yet any combination of arteries may be used for a repair.
- •Diameter of vessel(s) to be incorporated into endograft
- 另有 45 项未显示
排除标准
- •Patient can be treated in accordance with the instructions for use with a commercially marketed endovascular prosthesis
- •Patient qualifies for treatment of thoracoabdominal aortic repair under an industry-sponsored clinical trial, open to enrollment at the Massachusetts General Hospital & Brigham and Women's Hospital
- •History of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately
- •Known sensitivity or allergy to materials of construction of the device (including the materials of the LP device).
- •Body habitus that would inhibit X-ray visualization of the aorta
- •Subject had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned <30 days from the endovascular repair
- •Unstable angina
- •Unwilling to comply with follow up schedule
- •Systemic or local infection that may increase the risk of endovascular graft infection
- •An uncorrectable coagulopathy
研究组 & 干预措施
Ascending Aortic Arm
Experimental
Investigational endovascular stent-graft implantation to exclude aneurysm or repair dissection of the ascending aorta.
干预措施: Endovascular stent-graft implantation (Device)
Arch Branch Arm
Experimental
Investigational endovascular stent-graft implantation to exclude aneurysm or repair dissection of the aortic arch.
干预措施: Endovascular stent-graft implantation (Device)
Thoracoabdominal Aortic Arm
Experimental
Investigational endovascular stent-graft implantation to exclude thoracoabdominal aortic pathology including aortic aneurysms, renal artery aneurysms, and superior mesenteric artery aneurysms.
干预措施: Endovascular stent-graft implantation (Device)
结局指标
主要结局
Stroke and TIA
时间窗: 30 days
Freedom from peri-operative neurologic event
All-cause mortality
时间窗: 5 years
Freedom from death in perioperative and follow up time period
Aneurysm-related death
时间窗: 5 years
Freedom from aneurysm death related to reintervention or incomplete repair
次要结局
未报告次要终点
研究者
Matthew Eagleton
Physician Sponsor/PI
Massachusetts General Hospital
研究点 (3)
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