NCT01524211招募中不适用
Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
Baptist Health South Florida2 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2012年1月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 235
- 试验地点
- 2
- 主要终点
- Early Mortality & Stroke
研究概览
简要总结
Zenith t-Branch Study Cohort: The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system and the Terumo Arch Branch for the treatment of aortic aneurysms.
Terumo Arch Branch Study Cohort: The purpose of this additional study arm to the current IDE clinical trial is to collect a priori information on the Terumo Arch Branch Endograft for the treatment of proximal thoracic aortic pathologies that cannot be treated with conventional thoracic endografts.
详细描述
Study Update as of 3/31/2025; 186 subjects successfully have been implanted with the Zenith t-Branch Device and 1 subject has been implanted with the Arch Branch to date and recruitment is ongoing.
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
- •Zenith t-Branch Eligibility Criteria:
- •Inclusion Criteria
- •The patient must have one of the following:
- •Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular):≥55mm in diameter in a male or ≥50mm in diameter in a female, or
- •Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or
- •Penetrating ulcers: ≥20mm in depth or
- •Chronic type B aortic dissections: ≥50mm total aortic diameter or
- •Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size.
- •Additional criteria for LP material
- •Iliofemoral access vessels <8mm or with significant atherosclerotic occlusive disease that would require an iliac conduit as determined by the Principle Investigator
排除标准
- •General Criteria
- •Life-expectancy less than 12 months
- •Refusal to receive blood products
- •Age <18 years
- •Pregnant or breastfeeding or planning on becoming pregnant within 60 months
- •Unwilling to comply with the follow-up schedule
- •Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized
- •Medical Criteria
- •Uncontrolled systemic infection
- •Untreatable malignancy
- •Uncontrollable anaphylaxis to iodinated contrast
- •Known allergy(ies) to device materials
- •Anatomic Criteria
- •Any pathology of mycotic origin
- •Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
- •Inability to insert the Zenith® t-Branch device through iliofemoral approach
- •Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm
- •Proximal landing zone length <25mm to allow secure fixation and seal
- •Proximal landing zone diameter of <24mm or >42mm
- •Distal landing zone length <25mm in the abdominal aorta or <20mm in the iliac arteries
- •Distal landing zone diameter of <14mm or >30mm in the abdominal aorta, or <7mm or >28mm in the iliac arteries
- •Terumo Arch Branch Eligibility Criteria
- •Inclusion Criteria
- •The subject must have one of the following:
- •Degenerative, atherosclerotic aneurysm involving the ascending aorta, aortic arch or proximal descending aorta ≥55 mm in diameter or > 50 mm with a history of growth ≥5 mm in the last 6 months, or
- •Penetrating ulcers: ≥20 mm in depth, or
- •Chronic aortic dissections: ≥50mm total aortic diameter. AND Prohibitive or high-risk for standard open surgical repair, defined as having one or more of the following pre-existing conditions.
- •Age >85 years old.
- •Prior median sternotomy (for any reason).
- •Prior open or endovascular thoracic aortic repair.
- •Severe aortic calcification.
- •Severe occlusive disease of one or more arch vessels.
- •Moderate-severe COPD (FEV1 <80% predicted).
- •Severe CKD (Stage 3 or greater, eGFR <60 mL/min).
- •LV dysfunction.
- •Chronic steroid or immunosuppressive use.
- •History of increased risk of bleeding.
- •Neurocognitive deficits that may significantly impact postoperative rehabilitation.
- •Musculoskeletal conditions that may significantly impact postoperative rehabilitation.
- •Exclusion Criteria
- •General Criteria
- •Life expectancy <1 year.
- •Refusal to receive blood products.
- •Age <18 years.
- •Pregnant, breastfeeding, or planning to become pregnant within 60 months.
- •Unwilling to comply with the follow-up schedule.
- •Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized.
- •Willingness to travel, if needed, to participate in a manufacturer-sponsored clinical trial at another institution.
- •Medical Criteria
- •Pending cardiac surgery.
- 另有 24 项未显示
结局指标
主要结局
Early Mortality & Stroke
时间窗: 30 days post implant of the branch endografts
The primary aim of this study is to determine the rate of early mortality and stroke after branch endograft treatment.
次要结局
- Rates of Neurologic Complications/Late Branch Vessel Patency(Day 0-Day 30 (Early) Day 31-1825 (Late))
研究者
研究点 (2)
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