NCT03108456进行中（未招募）不适用
Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,005
- 试验地点
- 205
- 主要终点
- Target Vessel Failure (TVF)
研究概览
简要总结
This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).
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
- 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 or older.
- •Subject presents with:
- •stable ischemic heart disease or
- •acute coronary syndrome (NSTEMI or unstable angina), or
- •stabilized recent STEMI (>48 hours prior to randomization procedure)
- •Subject has signed the Institutional Review Board (IRB) or Ethics Committee (EC) approved ECLIPSE trial Informed Consent Form (ICF) prior to any trial related procedures.
- •General Exclusion Criteria
- •Subject has a history of any cognitive or mental health status that would interfere with trial participation.
- •Subject is participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint.
- •Subject is a female who is pregnant.
- •Subject is receiving or scheduled to receive chemotherapy within thirty (30) days prior or any time after the randomization procedure.
- •Subject has a life expectancy of ≤ 12 months.
- •Subject has undergone any prior PCI in the target vessel or its branches 12 months prior to randomization.
- •Subject has undergone a PCI procedure that is unsuccessful or with complications within 30 days prior to randomization, including during the randomization procedure.
- •Any cardiac intervention or cardiac surgery planned within 12 months post randomization procedure aside from a potential planned staged PCI as part of the randomized treatment strategy.
- •Subject has major valve disease and underwent intervention within 30 days prior to randomization.
- •Subject has received a heart transplant.
- •Evidence of heart failure by at least one of the following (heart failure assessment is not required per protocol but must be reviewed prior to enrollment if data is available):
- •Most recent LVEF ≤25%, or
- •Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or
- •Killip class ≥2 (post STEMI patients)
- •Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only.
- •Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated.
- •Subject has a relative or absolute contraindication to dual antiplatelet therapy or (for patients with atrial fibrillation) single antiplatelet therapy (P2Y12 inhibitor preferred) with an anticoagulant for at least 6 months after PCI.
- •Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months prior to randomization, or any permanent neurologic deficit.
- •Subject has a history of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
- •Subject has evidence of an active infection on the day of the randomization procedure requiring oral or intravenous antibiotics.
- •Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.
排除标准
- 未提供
结局指标
主要结局
Target Vessel Failure (TVF)
时间窗: 1-Year
Target vessel failure, defined as the composite of cardiac death, target vessel related myocardial infarction (MI), or ischemia-driven target vessel revascularization.
Acute Minimum Stent Area (MSA)
时间窗: Procedure
In-stent minimal cross-sectional area as assessed by optical coherence tomography (OCT) at the conclusion of the procedure in the OCT imaging cohort.
次要结局
- Procedural Success(Procedure)
- Strategy Success(Procedure)
研究者
研究点 (205)
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