NCT07089576招募中不适用
A Prospective, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA in the Open Repair of Aortic Arch Aneurysms and Dissections
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 23
- 主要终点
- Composite Rate of Patients Free From ≥1 Major Adverse Event
研究概览
简要总结
The goal of this clinical trial is to learn if the Arcevo LSA stent graft can safely and effectively treat patients that have an acute or chronic aortic dissection and/or aneurysm that involves the aortic arch and the descending thoracic aorta, with or without the involvement of the ascending aorta.
研究设计
- 研究类型
- 干预性
- 分配方式
- 非随机
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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
- General Inclusion Criteria
- ≥18 years of age or ≤80 years of age (male or female) at time of surgery
- Patient has one of the following indications for open surgery based on computed tomography angiography (CTA) completed within 90 days of informed consent:
- Acute, subacute, or chronic dissection that involves the aortic arch and the descending thoracic aorta, with or without involvement of the ascending aorta
- Aneurysm that involves the aortic arch and the descending thoracic aorta, with or without involvement of the ascending aorta
- Patient, or patient's legally authorized representative (LAR; in the secondary arm only), provides written informed consent prior to any study procedures
- Patient's surgery occurs within 90 days of informed consent Anatomical Inclusion Criteria
- Aortic diameter at the intended Arcevo™ LSA anastomosis site is ≥ 21 mm
- For Aneurysm with distal sealing (i.e., single stage procedure), aortic diameter at the intended distal sealing zone is between 20-36 mm
- For Dissection with distal sealing, aortic diameter at the intended distal sealing zone is between 22-40 mm
- LSA branch does not require additional stenting further into the LSA (beyond the Arcevo™ LSA)
- The intended LSA sealing zone has a diameter between 8.5 mm and 14.0 mm with a length of at least 10 mm
- Absence of dissection, aneurysm, or stenosis in the intended LSA sealing zone
- The intended LSA branch position does not interrupt flow to any branch vessel (e.g., left vertebral artery)
- Patient does not have computed tomography (CT) evidence of extreme arch or LSA angulation precluding safe passage of the Arcevo™ LSA and delivery system
- LSA take-off angle between 15° and 90°
- For patients requiring planned extension, there is a ≥ 2 cm distal seal zone for the TEVAR device without a severely angulated descending aorta
- For patients requiring planned extension, patient has suitable iliac artery anatomy for safe passage of the TEVAR delivery system
- General
排除标准
- Patient is pregnant, or planning to become pregnant during the course of the study; individuals of child-bearing potential must agree to use acceptable methods of contraception during the study
- Patient has another medical condition (aside from the arch disease) that, in the opinion of the investigator, reduces the patient's life expectancy to < 2 years
- Patient has an existing aortic stent graft device in the descending aorta that would interact with Arcevo™ LSA
- Patient has a medical, social, or psychological problem that, in the opinion of the investigator, could impede the patient's ability to return for follow-up
- Patient is unwilling or unable to comply with the follow-up schedule
- Patient is institutionalized due to administrative or judicial order
- Patient is unwilling to accept blood transfusion or blood product
- Patient is currently participating in another interventional clinical study which includes treatment with another investigational product (e.g., device, pharmaceutical or biologic) Medical Exclusion Criteria
- Patient is unfit for open surgical repair involving circulatory arrest
- Patient is in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR) or substantial inotropic support prior to surgery
- Patient has an active systemic infection
- Patient has endocarditis or active infection of the aorta
- Patient has a freely ruptured aorta
- Patient has a history of a bleeding disorder (e.g., hemophilia)
- Patient has current end-stage renal disease (e.g., GFR <30 mL/min)
- Patient has a known allergy to Arcevo™ LSA components and TEVAR device components (if required) (nitinol, polyester, platinum-iridium, or polyethylene)
- Patient has uncontrollable anaphylaxis to iodinated contrast or other inability to obtain CT angiograms during follow-up
- Patient has acute coronary malperfusion
- Patient has symptomatic visceral malperfusion
研究组 & 干预措施
Arcevo LSA
Experimental
The Primary study arm will consist of patients with an aortic aneurysm or chronic aortic dissection (n=117).
The Secondary study arm will include patients with acute or subacute aortic dissections (n=15).
干预措施: Arcevo™ LSA Hybrid Stent Graft System (Device)
结局指标
主要结局
Composite Rate of Patients Free From ≥1 Major Adverse Event
时间窗: 1 year post-index procedure of LSA stent graft implant
The major adverse events included in the composite are: * All-cause mortality * New permanent disabling stroke * New permanent paraplegia and/or paraparesis * Unanticipated aortic reoperation in the treated segment * LSA occlusion
次要结局
- Rate of Patients with Major Adverse Events(Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure)
- Rate of Patients with Radiographic Events (determined by Core Lab)(Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure)
- Rate of Patients Requiring a Thoracic Extension Procedure who Experience Device-Extension Failure(Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure)
- Rate of Patients with ≥1 Additional Aortic Procedure(Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure)
- Rate of Mortality(Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure)
- Rate of Patients with ≥1 Device-Related Event(Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure)
- Rate of Patient Requiring a Thoracic Extension Procedure with Evidence of Type IIIa Endoleak(Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of index procedure)
- Rate of Patients Requiring Thoracic Extension Procedure with Failed Patency(Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure)
- Rate of Patients Requiring Thoracic Extension Procedure with ≥1 Primary Major Adverse Events(30 days post-extension procedure)
- Rate of Patients Requiring Thoracic Extension Procedure Requiring ≥1 Secondary Procedure Related to Extension(30 days post-extension procedure)
研究者
研究点 (23)
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标识符
- NCT 编号
- NCT07089576
- 其他研究编号
- ART2401.000-C
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (明年)
- 研究完成日期
- (5年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 是
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
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