TRUST Registry - Targeting Real World Usage In Stroke Treatment A WallabyPhenox Hemorrhagic Stroke Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Phenox GmbH
- 入组人数
- 5,000
- 试验地点
- 13
- 主要终点
- Morbi-mortality
研究概览
简要总结
TRUST Registry is an observational, prospective, long-term, post-market surveillance registry of subjects treated with WallabyPhenox flow modulation devices, stent systems, bifurcation aneurysm implants including their HPC variants (Hydrophilic Polymer Coating) where applicable as well as coil systems, and other adjunctive medical devices.
The overarching purpose of this registry is to carry out a proactive gathering, recording, and analysis of data on the safety, performance and usability of the devices as applied within the routine practice of the participating registry sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject treated or intended to be treated with at least one target registry device during the procedure (i.e., at least one attempt of introduction into the vasculature of the subject),
- •Non-opposition to data collection or informed consent provided by the subject or legal representative as per country-specific legislation.
排除标准
- •Participation in an interventional study modifying standard care management for all relevant indications,
研究组 & 干预措施
Treatment of Intracranial Aneurysm
Patients undergoing treatment for intracranial aneurysms (IA) with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.
The cohort originates from one overarching registry protocol.
干预措施: Aneurysm Treatment with a Neurovascular Flow Diverter (Device)
Treatment of Intracranial Aneurysm
Patients undergoing treatment for intracranial aneurysms (IA) with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.
The cohort originates from one overarching registry protocol.
干预措施: Aneurysm Treatment with Neurovascular Stent System (Device)
Treatment of Intracranial Aneurysm
Patients undergoing treatment for intracranial aneurysms (IA) with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.
The cohort originates from one overarching registry protocol.
干预措施: Aneurysm treatment with Bifurcation Aneurysm Implant (Device)
Treatment of Intracranial Aneurysm
Patients undergoing treatment for intracranial aneurysms (IA) with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.
The cohort originates from one overarching registry protocol.
干预措施: Aneurysm treatment with Avenir Coil System (Device)
Treatment of Vascular Dissection
Patients undergoing treatment for vascular dissection with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.
The cohort originates from one overarching registry protocol.
干预措施: Dissection Treatment with a Neurovascular Flow Diverter (Device)
Treatment of Vascular Dissection
Patients undergoing treatment for vascular dissection with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.
The cohort originates from one overarching registry protocol.
干预措施: Dissection Treatment with Neurovascular Stent System (Device)
Treatment of Vascular Perforation
Patients undergoing treatment for vascular perforation with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.
The cohort originates from one overarching registry protocol.
干预措施: Perforation Treatment with a Neurovascular Flow Diverter (Device)
Treatment of Neurovascular Abnormalities
Patients undergoing treatment for neurovascular abnormalities with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.
The cohort originates from one overarching registry protocol.
干预措施: Arteriovenous Fistula treatment with a Neurovascular Flow Diverter (Device)
Treatment of Neurovascular Abnormalities
Patients undergoing treatment for neurovascular abnormalities with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.
The cohort originates from one overarching registry protocol.
干预措施: Arteriovenous fistula treatment with Avenir Coil System (Device)
Treatment of Atherosclerotic Vascular Stenosis of Intracranial Arteries
Patients undergoing treatment for atherosclerotic vascular stenosis of intracranial arteries with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol.
干预措施: Atherosclerotic vascular stenosis Treatment with Neurovascular Stent System (Device)
结局指标
主要结局
Morbi-mortality
时间窗: Morbi-mortality related to the device/procedure will be assessed at 365 days, in alignment with the standard of care of the participating sites.
Morbi-mortality will be defined by a modified Rankin Scale (mRS) ≥ 3 in patients with an mRS ≤ 2 prior to the procedure, or at least 1-point increase over the initial mRS score in subjects with an mRS \> 2 prior to the procedure. The scale runs from 0-6 and is presented as below: 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead
次要结局
- Performance - Aneurysm Occlusion Rate(The performance outcomes is assessed at the end of the procedure and at 12 months (± 6 months) in alignment with the standard of care of participating sites.)
- Performance - Incidence of Aneurysm Re-canalization/ Recurrence/ Regrowth(The performance outcomes are collected at relevant time-points (e.g., 180 days, 365 days, annually up to 5 years post-procedure), in alignment with the standard of care of participating sites.)
- Performance - Aneurysm Re-treatment Rate(The performance outcomes are collected at relevant time-points (e.g., 180 days, 365 days, annually up to 5 years post-procedure), in alignment with the standard of care of participating sites.)
- Performance - Vascular dissections sealing(The performance outcomes is assessed at the end of the procedure and at 12 months (± 6 months) in alignment with the standard of care of participating sites.)
- Performance - Vascular perforation sealing(The performance outcomes is assessed at the end of the procedure and at 12 months (± 6 months) in alignment with the standard of care of participating sites.)
- Performance - Arteriovenous fistula (AVF) Occlusion Status(The performance outcomes is assessed at the end of the procedure at early stage post procedure (5 ± 2 months) and at 12 months (± 6 months) in alignment with the standard of care of participating sites.)
- Performance - Incidence of In-stent Stenosis(The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites.)
- Performance - Device Technical Success(Device Technical Success is assessed at the end of the procedure.)
- Safety - Incidence of hemorrhagic, thromboembolic, neurological, or other procedural complications(Assessed at relevant time-points (e.g., periprocedural, 180 days, 365 days, annually up to 5 years post-procedure) in alignment with the standard of care of participating sites.)
- Safety - Rate of Major Strokes and Neurological Death(Depending on the standard of care of the participating sites, e.g. 180 days, 365 days or annually up to 5 years post-procedure.)
- Safety - Incidence of Device deficiencies(Assessed periprocedural and at relevant time-points (e.g., 180 days, 365 days, annually up to 5 years post-procedure) in alignment with the standard of care of participating sites.)
- Usability(During the procedure)
- Performance - Average residual stenosis(The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites.)