Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,090
- 试验地点
- 151
- 主要终点
- Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
研究概览
简要总结
The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study.
Subjects must sign an ICF prior to obtaining any study specific information. Subjects are eligible to be consented up to 30 days post-procedure.
Enrolled subjects will be followed as per local 'standard of care' for up to 5 years post procedure. Study recommended follow-up is per SVS and ESVS guidance.
详细描述
The objective of the ANCHOR registry is to expand the clinical knowledge based on the use of the Heli-FX™ EndoAnchor™ System. This registry will include "real world" use over a broad spectrum of geographies, by a wide variety of practicing clinicians, and with a minimal degree of subject selection criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Protocol B:
- •Inclusion criteria:
- •Subjects with asymptomatic, symptomatic, or ruptured aortic aneurysms
- •Subject ≥ 18 years old
- •Subject has provided written informed consent, either before or less than or equal to 30 calendar days after the index procedure
- •Subject is willing and able to comply with standard of care followup evaluations
- •Subject has a previously implanted endograft or will be undergoing repair, with one of the following aortic aneurysm endograft devices:
- •Cook Zenith or Cook Zenith TX2
- •Gore Excluder or TAG
- •Medtronic AneuRx
- •Medtronic Talent
- •Medtronic Endurant or Valiant
- •Any additional third party AAA endograft device that is commercially available and listed as compatible with Heli-FX™ in the IFU
- •Subject's iliac/femoral access is compatible with:
- •a 16 French sheath (abdominal subjects)
- •18 French sheath (thoracic subjects)
- •Selected 16 or 18 French sheath, as applicable to the device selected for use (advanced disease subjects)
- •Subject has a previously implanted endograft that has migrated or has a Type I endoleak within the aorta or will undergo implantation of an endograft that in the opinion of the investigator will be at increased risk of such complications
排除标准
- •Subject has known allergy to the EndoAnchor™ implant material (nickel, chromium, molybdenum, or cobalt)
- •Subject has a life expectancy of less than 1 year
- •Subject is participating in a clinical study or registry that, in the Investigator's opinion, may conflict or may have a negative impact on the subject's safety
- •Subject was treated with EndoAnchor™ in the same segment of the aorta that will be treated in the registry
- •Subject has an active or known history of bleeding diathesis
- •Subject has a condition that threatens to infect the endograft (active bacteremia, or infections that carry increased risk of endograft infection)
- •Significant thrombus or calcium at the location of planned EndoAnchor™ implantation that precludes adequate EndoAnchor™ penetration of the aortic wall
- •Use where, for whatever reason, each EndoAnchor™ is not anticipated to adequately penetrate into the aortic wall
- •Subject has an aortic dissection that involves an area to be treated with EndoAnchor™
- •Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease
- •Subject is pregnant
- •Protocol C:
- •Inclusion criteria:
- •Subjects with asymptomatic or symptomatic abdominal aortic aneurysms that will receive the Heli-FX™ in conjunction with the Endurant II/IIs endograft as part of their planned EVAR treatment
- •Subject ≥ 18 years old
- •Subject has provided written informed consent, either before or less than or equal to 30 calendar days after the index procedure
- •Subject is willing and able to comply with standard of care followup evaluations
- •Subject will be undergoing AAA repair with the bifurcated main body Endurant II/IIs stent graft in conjunction with Heli-FX™ with a proximal neck length of ≥ 4mm to < 10mm and treated in accordance with the Endurant II/IIs and Heli-FX™ IFUs
- •Subject's iliac/femoral access is compatible with a 16 French sheath
- •Exclusion criteria:
- •Subject has known allergy to the EndoAnchor™ implant material (nickel, chromium, molybdenum, or cobalt)
- •Subject has a life expectancy of less than 1 year
- •Subject is participating in a clinical study or registry that, in the Investigator's opinion, may conflict or may have a negative impact on the subject's safety
- •Subject was previously treated with EndoAnchor™ implants in the same segment of the aorta that will be treated within the registry, or has a previously implanted AAA endograft that has migrated or has a Type Ia endoleak, or is being treated for a ruptured abdominal aortic aneurysm, or has planned usage of an Endurant II/IIs AUI main body stent graft configuration
- •Subject has an active or known history of bleeding diathesis
- •Subject has a condition that threatens to infect the endograft (active bacteremia, or infections that carry increased risk of endograft infection)
- •Significant thrombus or calcium at the location of planned EndoAnchor™ device implantation that precludes adequate EndoAnchor™ implant penetration of the aortic wall
- •Use where, for whatever reason, each EndoAnchor™ implant is not anticipated to adequately penetrate into the aortic wall
- •Subject has an aortic dissection that involves an area to be treated with EndoAnchor™ implants
- •Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease
- •Subject is pregnant
- •Physician does not intend to treat subject on-label per the Endurant II/IIs and Heli-FX™ IFU requirements or if the physician intends to use Heli-FX™ in a chimney procedure.
研究组 & 干预措施
Protocol B, abdominal arm, revision group
AAA subjects with previously implanted commercial endografts for the treatment of graft migration and/or Type Ia endoleak
干预措施: EndoAnchor™ (Device)
Protocol B, abdominal arm, revision group
AAA subjects with previously implanted commercial endografts for the treatment of graft migration and/or Type Ia endoleak
干预措施: endovascular treament (Procedure)
Protocol B, abdominal arm, primary group
AAA subjects at the time of initial endograft implantation either to prevent endograft migration and Type Ia endoleak, or to treat Type Ia endoleak evident at the time of implantation.
干预措施: EndoAnchor™ (Device)
Protocol B, abdominal arm, primary group
AAA subjects at the time of initial endograft implantation either to prevent endograft migration and Type Ia endoleak, or to treat Type Ia endoleak evident at the time of implantation.
干预措施: endovascular treament (Procedure)
Protocol B, thoracic arm, revision group
TAA subjects with previously implanted commercial endografts for the treatment of migration and/or Type Ia and/or Type Ib endoleak at the proximal or distal attachment site
干预措施: EndoAnchor™ (Device)
Protocol B, thoracic arm, revision group
TAA subjects with previously implanted commercial endografts for the treatment of migration and/or Type Ia and/or Type Ib endoleak at the proximal or distal attachment site
干预措施: endovascular treament (Procedure)
Protocol B, thoracic arm, primary group
TAA subjects at the time of initial endograft implantation either to prevent endograft migration and Type I endoleak, or to treat Type Ia and/or Ib endoleak at the proximal or distal attachment site evident at the time of implantation
干预措施: EndoAnchor™ (Device)
Protocol B, thoracic arm, primary group
TAA subjects at the time of initial endograft implantation either to prevent endograft migration and Type I endoleak, or to treat Type Ia and/or Ib endoleak at the proximal or distal attachment site evident at the time of implantation
干预措施: endovascular treament (Procedure)
Protocol B, advanced disease arm, revision group
Advanced disease subjects with previously implanted commercial endografts for the treatment of migration and/or Type Ia and/or Type Ib endoleak at the proximal or distal attachment site
干预措施: EndoAnchor™ (Device)
Protocol B, advanced disease arm, revision group
Advanced disease subjects with previously implanted commercial endografts for the treatment of migration and/or Type Ia and/or Type Ib endoleak at the proximal or distal attachment site
干预措施: endovascular treament (Procedure)
Protocol B, advanced disease arm, primary group
Advanced disease subjects at the time of initial endograft implantation either to prevent endograft migration and Type I endoleak, or to treat Type Ia and/or Ib endoleak at the proximal or distal attachment site evident at the time of implantation.
干预措施: EndoAnchor™ (Device)
Protocol B, advanced disease arm, primary group
Advanced disease subjects at the time of initial endograft implantation either to prevent endograft migration and Type I endoleak, or to treat Type Ia and/or Ib endoleak at the proximal or distal attachment site evident at the time of implantation.
干预措施: endovascular treament (Procedure)
Protocol C, abdominal arm, short neck, primary group
Planned use of Heli-FX™ in conjunction with the Endurant II/IIs endograft in AAA subjects with short proximal necks (≥ 4 mm and < 10 mm) in primary group.
干预措施: EndoAnchor™ (Device)
Protocol C, abdominal arm, short neck, primary group
Planned use of Heli-FX™ in conjunction with the Endurant II/IIs endograft in AAA subjects with short proximal necks (≥ 4 mm and < 10 mm) in primary group.
干预措施: endovascular treament (Procedure)
结局指标
主要结局
Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
时间窗: Through 12 months
The primary safety endpoint is defined by: i. freedom from device-related serious adverse events at 12 months and ii. freedom from procedure-related serious adverse events at 12 months iii. freedom from aneurysm-related mortality defined as: i. death within 30 days of the index procedure ii. death within 30 days of a secondary procedure to address the aneurysm iii. death from rupture of the treated aneurysm
Protocol B has composite primary effectiveness endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
时间窗: Through 12 months
The primary effectiveness endpoint requires all of the following: i successful implantation of the minimum number of EndoAnchor™ and ii freedom from migration at 12 months and iii freedom from Type I endoleak at the targeted attachment site(s) at 12 months
Protocol C have composite primary effectiveness endpoint
时间窗: Through 12 months
The primary effectiveness endpoint is treatment success which is defined as the successful implantation of EndoAnchor™ implants at the index procedure, and the absence of: 1. migration at 12 months and 2. Type I endoleak at the targeted attachment site(s) at 12 months
Protocol C has composite primary safety endpoint
时间窗: Through 12 months
The primary safety endpoint is defined by: 1. device-related serious adverse events at 12 months 2. aneurysm-related mortality defined as: i. death within 30 days of the index procedure ii. death within 30 days of a secondary procedure to address the aneurysm iii. death from rupture of the treated aneurysm
次要结局
- Protocol B has the secondary endpoints chosen to reflect the clinical success and safety of Heli-FX™. Each of the secondary endpoints will be measured individually at 30 days and 12 months and yearly thereafter.(Through 5 years)
- Protocol C has the secondary endpoints chosen to reflect the clinical success and safety of Heli-FX™. Each of the secondary endpoints will be measured individually at 30 days and 12 months and yearly thereafter.(Through 5 years)