NCT03423511尚未招募不适用
CRYSTAL Study: A Multi-Center, Randomized, Controlled Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries.
Micell Technologies0 个研究点目标入组 1,300 人开始时间: 2021年12月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,300
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
To compare MiStent to either the Xience or Promus stents.with the primary objective being to assess the safety and efficacy of the MiStent in a patient population requiring revascularization of de novo obstructive lesions of coronary arteries in patients with stable and unstable coronary artery disease (CAD) including non ST-Elevation Myocardial Infarction (NSTEMI)
详细描述
The CRYSTAL study is a prospective, multi-center, randomized (1:1), single-blinded and controlled, investigational device exemption trial to test the non-inferiority of MiStent to commercially available "everolimus" drug eluting stents (Xience and Promus stents).
Patients with coronary artery disease (CAD) that qualify for percutaneous coronary intervention (PCI) with stenting will be screened per the protocol inclusion and exclusion criteria.
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
- Single (Participant)
盲法说明
This is a single-blind trial, such that the patient or patient's family will NOT be told which stent they have received.
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 must be ≥ 18 years of age
- •Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
- •Subject is eligible for percutaneous coronary intervention (PCI)
- •Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
- •Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
- •Subject is willing to comply with all protocol-required follow-up evaluation
- •Angiographic Inclusion Criteria (visual estimate):
- •Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.50 mm and ≤3.50 mm
- •Target lesion(s) must be able to be treated with a single stent and the target lesion length must be ≤27 mm (by visual estimate).
- •NOTE: Only lesion lengths that have both the control and comparable investigational stent lengths available at the same time are eligible for enrollment.
- •Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following:
- •Stenosis ≥70% or;
- •Abnormal fractional flow reserve (FFR) defined as <0.80 or;
- •Abnormal stress or imaging stress test or;
- •Elevated biomarkers prior to the procedure
- •Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
- •The first lesion treated must be successfully predilated/pretreated
排除标准
- •Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
- •Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
- •Subject has received an organ transplant or is on a waiting list for an organ transplant
- •Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
- •Planned PCI (including staged procedures) or CABG after the index procedure
- •Subject previously treated at any time with intravascular brachytherapy in the target vessel(s)
- •Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., Cobalt-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
- •Subject has one of the following (as assessed prior to the index procedure):
- •Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months
- •Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
- •Planned procedure that may cause non-compliance with the protocol or confound data interpretation
- •Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin, or other anticoagulation therapy) for indications other than acute coronary syndrome
- •Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
- •Subject has a white blood cell (WBC) count < 3,000 cells/mm3
- •Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
- •Subject is on dialysis or has baseline glomerular filtration rate (GFR) of <30 ml/min
- •Subject has a history of bleeding diathesis, active peptic ulcer or gastrointestinal (GI) bleed, or coagulopathy or will refuse blood transfusions
- •Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
- •Subject has severe symptomatic heart failure (i.e., Left Ventricular Ejection Fraction (LVEF) <30%))
- •Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
- •Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
- •Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)
- •Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
- •Angiographic Exclusion Criteria (visual estimate):
- •Planned treatment of a single lesion with more than 1 stent
- •Planned treatment of more than 3 lesions
- •Planned treatment of lesions in more than 2 major epicardial vessels
- •Planned treatment of more than 2 lesions in a single major epicardial vessel
- •Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
- •Target lesion(s) is located in the left main or unprotected left
- •Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate
- •Target lesion(s) is located within a saphenous vein graft or an arterial graft
- •Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
- •Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
- •Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
- •Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
- •Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
- •Significant thrombus, present in the target vessel (by visual estimate)
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: through 12-month visit
Any occurrence of Target Lesion Failure (TLF) TLF is defined as: Cardiac death, or Target vessel myocardial infarction (TV-MI, Q-wave and non Q-wave), or Ischemia driven target lesion revascularization.
次要结局
- Composite Endpoint TLF(prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up)
- Mortality(prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up)
- Technical success(Index Procedure)
- Composite Endpoint TVF(prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up)
- Serious Adverse Events (SAEs)(prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up)
- Device success(Index Procedure)
- Procedural success(Index Procedure)
- Composite Endpoint POCE(prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up)
- Composite Endpoint MACE(prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up)
- Myocardial Infarction(prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up)
- Revascularization(prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up)
- Stent thrombosis rates(prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up)
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