Shockwave Assisted Large Bore Access (TAVR, TEVAR, EVAR, FEVAR)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Successful advancement of planned large bore access device
研究概览
简要总结
Annually, 150-200 TAVR with unilateral large bore access and 200 combined TEVAR/EVAR/FEVAR with bilateral large bore access are performed at our institution. Nearly 50 percent of patients fall outside IFU for access vessel size. Adjuncts described include iliac conduit, crack and pave, balloon expandable sheaths, direct aortic puncture, transcaval delivery, alternative access point (i.e axillary, carotid). Each of these adjuncts comes with additional complication potential and by nature of being used less frequently than the standard femoral access makes the procedure more challenging.
The intervention the use of the Shockwave Medical, Inc. Peripheral Lithoplasty® System to achieve large bore access in patients whose vessels fall outside of the IFU suggested dimensions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age >18 years
- •Indicated for planned procedure requiring large bore (>12 French sheath) access
- •Mental capacity to provide informed consent
- •Iliac access vessel demonstrates >50% circumferential calcium
- •Iliac access vessel demonstrates maximum inner lumen diameter less than IFU for device required
- •Iliac access vessel demonstrates maximum outer wall diameter greater than or equal to IFU for device required
- •Preoperative CT angiogram, </= 5mm slices
- •Preoperative ABI/TP
- •Unsuccessful delivery of large bore sheath without adjunctive intervention
- •o Definition of unsuccessful = operator assessment of the following
- •Visible distortion of iliac artery calcification under fluoroscopy without forward progress of device
- •Adverse forward pressure application by operator
- •Failure of device to track with external pressure applied to abdomen
- •Patient intolerance of advancement (pain response) in awake patient
排除标准
- •Contraindicated for antiplatelet therapy (aspirin or plavix)
- •Planned iliofemoral surgical reconstruction in next 30 days
- •Prior common or external iliac artery stent placement
- •Prior aorto-iliac, aorto-femoral, or iliofemoral bypass present
- •Iliac access vessel demonstrates maximum outer wall diameter less than IFU for device required
- •Inability to obtain preoperative CTA (contrast allergy, CKD, etc)
- •Inability to traverse iliac segment with wire
- •Emergent procedure
研究组 & 干预措施
Standard POBA (plain old balloon angioplasty)
The first 50 patients will be pre-treated with standard POBA
干预措施: Plain old balloon angioplasty (Device)
Shockwave
The second 50 patients will be treated primarily with Shockwave
干预措施: Shockwave (Device)
结局指标
主要结局
Successful advancement of planned large bore access device
时间窗: Day 1
Technical success-defined as successful advancement of planned large bore access device without use of additional adjuncts (stenting, repeat shockwave treatment, high pressure balloon, alternative access pathway)
次要结局
未报告次要终点
研究者
Mathew Wooster
Assistant Professor
Medical University of South Carolina