WEDGES: a Prospective, Multi-center Randomized Trial for the Evaluation of Coronary Lesion Preparation With Enhanced Dilatation for Good Expansion of Stent: Assessment of a New Scoring Balloon by Quantitative Stent Enhanced Visualization
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Stent expansion in calcified lesions assessed by stent diameter calculation using quantitative and intravascular analysis after lesion preparation using a scoring balloon is superior to conventional lesion preparation
研究概览
简要总结
Stent under-expansion during percutaneous coronary intervention (PCI) is one of the suboptimal results associated with a higher risk of restenosis and thrombosis. In order to obtain an optimal stent expansion, especially in lesions with calcific or fibrotic plaque, the appropriate lesion preparation before stent implantation is a crucial phase.
For this, different devices are used in everyday practices, including non-compliant balloon (NC), scoring / cutting balloons or rotational atherectomy; however, their effectiveness depends on the experience and skill of the operator. The purpose of this study is to assess the feasibility, efficacy and safety of a novel scoring balloon intended to treat calcific or fibrotic plaque of a coronary lesion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient written consent is given A de novo lesion
- •Mild to moderate burden of calcifications detected on two orthogonal views using normal radiation power
排除标准
- •Exclusion criteria patient-related:
- •Patient <18 years old
- •Pregnant female
- •Contraindication to dual antiplatelet therapy
- •Thrombocytopenia <100 000
- •Major surgical intervention planned
- •Exclusion criteria lesion-related:
- •Significant left main lesion
- •Bifurcating lesion with a significant side branch to be treated
- •Lesion length > 25 mm
- •Chronic total occlusion
- •Lesion with heavy calcifications where a rotational atherectomy or lithotripsy should be planned
- •Lesion in a graft
- •In-stent restenosis lesion
- •Lesion responsible of a STEMI
结局指标
主要结局
Stent expansion in calcified lesions assessed by stent diameter calculation using quantitative and intravascular analysis after lesion preparation using a scoring balloon is superior to conventional lesion preparation
时间窗: Intravascular ultrasound (IVUS) or quantitative analysis is directly done after procedure
The measure of stent expansion in calcified coronary lesions as assessed by quantitative coronary angiography, enhanced stent imaging and intravascular ultrasound after lesion preparation using the novel scoring semi-compliant and noncompliant balloons are superior (p\<0.05) to semi compliant and non-compliant balloons.
次要结局
- Rate of residual under-expansion of stent after post-dilatation with a non-compliant balloon(Directly after procedure)
- Rate of successful predilatation of calcified lesions of a scoring semi-compliant/non-compliant balloon and semi-compliant (SC)/ non-compliant (NC) balloon(Directly after procedure)
- Rate of procedural complication (composite of cardiac death, myocardial infarction, coronary artery perforation and cardiac tamponade) of a scoring balloon and a SC/NC balloon followed by stenting.(1 month follow up)
研究者
Stephane Carlier
Professor
University of Mons