A Prospective, Multi-Center, Single-Arm, Real-World Study Assessing the Clinical Use of the Bard® UltraScore™ Focused Force PTA Balloon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 31
- 主要终点
- Number of Participants That Achieve Optimal PTA Results
研究概览
简要总结
The objective of this study is to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon in a heterogeneous patient population in a real world, on-label clinical application.
详细描述
The registry is a prospective, multi-center, single-arm, real-world study to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon for the treatment of stenotic lesions of the superficial femoral artery (SFA), popliteal artery, and infra-popliteal arteries (posterior tibial, anterior tibial and peroneal arteries). Follow-up for all treated subjects will be performed at hospital discharge, 30 days, and 6 and 12 months post-index procedure.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
- •Subject must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
- •Subject must be willing to comply with the protocol requirements, including the follow-up procedures.
- •Subject must have a target lesion (de novo lesion or prior failed treatment) that can be treated with the UltraScore™ Focused Force PTA balloon according to the Instructions for Use (IFU). Only a target lesion in the SFA, popliteal, or infra-popliteal arteries (posterior tibial, anterior tibial, or peroneal arteries) may be treated for this study.
- •Subject must have an Above the Knee (ATK) or Below the Knee (BTK) target lesion with at least one vessel run-off.
- •The target lesion must be able to be crossed using a guidewire (use of chronic total occlusion (CTO) or atherectomy is allowed).
排除标准
- •Subjects that are to receive one or more stents as adjunctive therapy at the target lesion (bail out stenting is allowed).
- •The subject has a single target lesion that involves both ATK and BTK arteries.
- •The subject has a target lesion in a previously placed stent or stent graft (in-stent restenosis).
- •The subject has a lesion, which in the opinion of the Investigator, would preclude safe use of the UltraScore™ Focused Force PTA balloon.
- •The subject has a flow limiting dissection at the target lesion prior to use of the UltraScore™ Focused Force PTA balloon.
- •The subject has acute limb ischemia.
- •The subject has been assessed Rutherford category
- •The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
- •The subject has another medical condition or is currently participating in an investigational drug or another device study that, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
结局指标
主要结局
Number of Participants That Achieve Optimal PTA Results
时间窗: Index procedure (Day 0); approximate duration of procedure is 90 minutes.
Optimal result is defined as ≤30% residual stenosis without major flow-limiting dissection, as measured by angiographic imaging. Major flow limiting dissections are classified by the National Heart, Lung, and Blood Institute (NHLBI) as Grade D (Spiral luminal filling defects), Grade E (Appearance of new and persistent filling defects with reduced flow), and Grade F (Total occlusion without distal flow).
Number of Participants With Technical Success of Use of UltraScore™ Focused Force PTA Balloon
时间窗: Index procedure (Day 0); approximate duration of procedure is 90 minutes.
Technical success is determined subjectively by the investigator according to delivery location of the study device relative to the target lesion, as assessed by angiographic imaging, and inflation without movement.
次要结局
- Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects(12 months post-index procedure)
- Number of Participants With Bail-out Stenting Due to Dissection(Index procedure (Day 0); approximate duration of procedure is 90 minutes.)
- Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).(12 months post-index procedure)
- Number of Participants That Did Not Have a Major Amputation of the Target Limb(12 months post-index procedure)
- Number of Participants That Had Improved Clinical Measures From Baseline (ABI)(12 months post-index procedure)
- Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)(12 months post-index procedure)