IN.PACT™ Quality of Life Post-Reimbursement Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Medtronic
- 入组人数
- 80
- 试验地点
- 9
- 主要终点
- Walking Ability Change
研究概览
简要总结
To prospectively collect and assess the perception of health-related Quality of Life, Pain and Walking Ability.
详细描述
To provide both the French National Authority for Health and the French Economic Committee for Health Products requested information on patient-reported outcomes for the IN.PACT™ Admiral™ Drug-Coated Balloon. Patients will be followed using routine clinical practice and the collection of two validated instruments: EuroQOL EQ-5D Quality of Life questionnaire and the Walking Impairment Questionnaire (WIQ).
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
- •Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- •Patient has or is intended to receive or be treated with an eligible product
- •Patient is consented within the enrollment window of the treatment/therapy received
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 (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness)
- •Note: For this study, de novo patients will be enrolled to assess EQ-5D and WIQ at baseline and follow-up. Patients cannot be treated in the same procedure with a competitor drug-coated (DCB) or drug-eluting (DES) in the vessel segment treated with IN.PACT Admiral.
结局指标
主要结局
Walking Ability Change
时间窗: Baseline & 12 months after endovascular procedure
Primary Objective: Assess the mean change of patient reported outcomes between pre-procedure visit (baseline) and 12 months after the endovascular procedure of the Walking Impairment Questionnaire (WIQ) (0 to 100% with 100% being better) in the treatment of de novo PTA subjects with obstructive disease of peripheral arteries with the IN.PACT™ Admiral™ DCB.
Quality of Life EQ-5D-5L French Index Score Change
时间窗: Baseline & 12 months after endovascular procedure
Primary Objective: Assess the mean change of patient reported outcomes between pre-procedure visit (baseline) and 12 months after the endovascular procedure of the EQ-5D-5L Questionnaire using the French Index Score (from -0.530 to 1.000 with 1 being better) in the treatment of de novo PTA subjects with obstructive disease of peripheral arteries with the IN.PACT™ Admiral™ DCB.
次要结局
- Quality of Life EQ-5D-5L French Index Score Change Over Time(Baseline, 30 days, 12 months and 24 months from the endovascular procedure)
- Walking Ability Change Over Time(Baseline, 30 days, 12 months and 24 months from the endovascular procedure)