NeuroVascular Product Surveillance Registry (PSR) Platform
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 199
- 主要终点
- Functional Independence: mRS score ≤ 2
研究概览
简要总结
Post market surveillance registry
详细描述
An observational, prospective, multi-center, single-arm registry to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic Neurovascular market-released products used in the treatment of Intracranial aneurysms and Acute Ischemic Stroke.
MDT16056 and MDT17077 are conducted under the Product Surveillance Registry (NCT01524276).
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
- •For MDT16056 and MDT17077
- •Inclusion Criteria:
- •Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
- •Patient has, or is intended to receive or be treated with, an eligible Medtronic product
- •Patient is consented within the enrollment window of the therapy received, as applicable
- •Patient is at least 18 years of age at time of enrollment.
排除标准
- •Patient who is, or is expected to be inaccessible for follow-up
- •Patient with exclusion criteria required by local law
- •Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
- •Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
- •For MDT24028 and MDT22032:
- •General Inclusion Criteria:
- •Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
- •Patient is treated or intended to be treated with an eligible Medtronic Neurovascular product.
- •Patient is an adult per local law at time of consent. Medtronic Business Restricted This document is electronically controlled CONFIDENTIAL 056-F275 Rev F Clinical Investigation Plan Template
- •General Exclusion Criteria:
- •Patient who may be unable to complete the study follow-up
- •Patient with any contraindications per the applicable Instructions for Use document
- •Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study
- •Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.
- •Additional criteria may be required, refer to cohort-specific Addendum, as applicable, for further guidance.
研究组 & 干预措施
Intracranial aneurysm
Patients undergoing treatment for intracranial aneurysms (IA) with Medtronic market approved device(s).
干预措施: Treatment for intracranial aneurysms (Device)
Acute Ischemic Stroke
Patients undergoing treatment for acute ischemic stroke (AIS) with Medtronic market approved device(s).
干预措施: Treatment for Acute Ischemic Stroke (Device)
结局指标
主要结局
Functional Independence: mRS score ≤ 2
时间窗: 90 days
For Acute ischemic stroke the primary outcome is functional Independence: modified Rankin Scale (mRS) score ≤ 2
The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).
时间窗: 1 year
For Intracranial Aneurysm the primary outcome is the clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).
次要结局
未报告次要终点