A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 57
- 主要终点
- Operative Death
研究概览
简要总结
The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.
Data will be collected both retrospectively and prospectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients must meet all of the following inclusion criteria in order to be eligible for inclusion in the study:
- •All Patients:
- •Patient meets the minimum age as per local regulations at time of consent
- •Patient requires treatment with study device(s) according to the IFU(s)
- •Patient is willing and able to comply with all SOC procedures and study visits
- •Patient or their legally authorised representative (LAR) has given written informed consent to participate in study, including consent to collect data retrospectively
- •For prospective emergency patients, retrospective consent is permissible
- •For retrospective patients who are deceased at time of enrollment, local EC regulations relating to consent process should be followed.
- •Retrospective Patients only:
- •Patient has a minimum of 1 year post-operative follow-up data available, or complete data to death.
- •Patient implant date is no more than 5 years prior to study start date.
排除标准
- •Any patient who meets any of the following exclusion criteria will be excluded from participation in the study:
- •Patient is unable or unwilling to comply with the SOC procedures or follow-up regime
- •Patient is contraindicated per the device IFU
- •Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post-procedure
研究组 & 干预措施
Gelsoft Plus - Straights and Bifurcated
Patients with aneurysmal or occlusive disease, including those with connective tissue disorders who have received/will receive a Gelsoft Plus Straight or Bifurcate, implanted in the abdomen or peripheral arteries in the last 5 years and from study launch onwards.
干预措施: Gelsoft Plus Vascular Graft (Device)
Gelsoft Plus - Extra-Anatomical
Any patients who have received/will receive a Gelsoft Plus Extra-Anatomical supported or unsupported graft, implanted for: axillary-femoral bypass, femoral-femoral bypass or femoral-popliteal bypass in the last 5 years and from study launch onwards.
干预措施: Vascular Bypass Graft (Device)
Cardiovascular Patches - Gelseal, Gelsoft, Thin Wall
Patients who have been implanted with/require a cardiovascular patch for: thoracic vessel repair with a Gelseal Cardiovascular Patch; abdominal or peripheral vessel repair with a Gelsoft Cardiovascular Patch; or carotid endarterectomy with a Thin Wall Carotid Patch in the last 5 years and from study launch onwards.
干预措施: Cardiovascular Patch (Device)
Gelweave - Abdominal, Thoracic, Thoracoabdominal
Patients who, due to either aneurysmal or occlusive disease, have had/require vascular repair of one of the following, implanted in the last 5 years and from study launch onwards:
- Abdominal aorta, arteries arising from the abdominal aorta or peripheral arteries including femoral, iliac and popliteal arteries.
- Thoracic aorta or arteries arising from the thoracic aorta.
- Abdominal and thoracic aorta requiring a thoracoabdominal repair
干预措施: Gelweave Vascular Graft (Device)
Gelweave - Valsalva
Patients who have had/require aortic root repair using valve sparing or valve replacing procedures, with or without replacement of the aortic arch, implanted in the last 5 years and from study launch onwards.
干预措施: Gelweave Valsalva Vascular Graft (Device)
结局指标
主要结局
Operative Death
时间窗: 1 Year
30 Day or In-Hospital Mortality
Graft Leakage
时间窗: 1 Year
Device Failure: The presence of leakage or excessive bleeding through graft/patch
次要结局
- Procedural Endpoints(1 Year)
- Safety Endpoints(1 Year)
- Device Endpoints(1 Year)