NCT06181240进行中（未招募）不适用
Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)
Bolt Medical46 个研究点 分布在 7 个国家目标入组 426 人开始时间: 2024年1月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 426
- 试验地点
- 46
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers.
详细描述
The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers with the Bolt Intravascular Lithotripsy System that was designed to percutaneous transluminal angioplasty by utilizing delivery of IVL to disrupt calcium prior to full balloon dilatation at low pressures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject is ≥18 years of age;
- •Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for Percutaneous Coronary Intervention (PCI);
- •For patients with unstable ischemic heart disease, a local site-based biomarker (preferably troponin or hs-troponin) must be less than or equal to the upper limit of lab normal (ULN) within 12 hours prior to the study procedure;
- •For patients with stable ischemic heart disease, CK-MB will be drawn at the time of the study procedure from the side port of the sheath; results need not be analyzed prior to enrollment, but must be less than or equal to the upper limit of lab normal (ULN);
- •Single de novo target lesion stenosis of protected LMCA, or LAD, RCA, or LCX (or of their branches) with:
- •Stenosis of ≥70% and <l00%; or
- •Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR <0.90, or IVUS or OCT minimum lumen area ≤4.0 mm2;
- •Evidence of calcification at the target lesion site by
- •angiography, with fluoroscopic radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, or
- •Intravascular Ultrasound (IVUS) or Optical Coherence Tomography (OCT), with presence of ≥270 degrees of calcium on at least 1 cross section;
- •Ability to pass a 0.014" guidewire across the lesion.
排除标准
- •Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure;
- •New York Heart Association (NYHA) class III or IV heart failure at time of index procedure;
- •Prospective need for hemodynamic support, i.e., IABP or Impella;
- •Chronic kidney disease with serum creatinine >2.5 mg/dL, eGFR <30 mL/min/1.73m2, or on chronic dialysis;
- •Unprotected left main diameter stenosis >50%;
- •Target vessel is excessively tortuous defined as the presence of two or more bends >90º or three or more bends >75º;
- •Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion;
- •Chronic Total Occlusion;
- •Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft;
研究组 & 干预措施
Bolt IVL System
Experimental
Lithotripsy is a medical procedure that uses shock waves to modify intravascular calcium.
干预措施: Intravascular lithotripsy (Device)
结局指标
主要结局
Primary Safety Endpoint
时间窗: Within 30 days following procedure
Freedom from major adverse cardiac events (MACE) within 30 days following the index procedure.
Primary Effectiveness Endpoint
时间窗: Immediately after the intervention/procedure/surgery
Procedural success defined as successful stent delivery with a final residual stenosis \<50% (assessed by angiographic core laboratory) and freedom from in-hospital MACE.
次要结局
- All deaths, cardiac deaths, MIs, TV-MIs, procedural and nonprocedural MIs, ID-TVRs, ID-TLRs, non-ID-TLRs, non-ID-TVRs, all revascularizations (ID and non-ID), and stent thrombosis(Periprocedure, within 30 days, 6 months, 12 months, and 24 months)
- Angiographic success (at <50%)(Immediately after the intervention/procedure/surgery)
- Device success(Immediately after the intervention/procedure/surgery)
- MACE(within 6, 12, and 24 months.)
- Procedural success(Immediately after the intervention/procedure/surgery)
- Angiographic success (at ≤30%)(Immediately after the intervention/procedure/surgery)
- Serious angiographic complications(Immediately after the intervention/procedure/surgery)
- Target lesion failure (TLF)(30 days, 6 months, 12 months, and 24 months)
研究者
研究点 (46)
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