NCT02072421已完成不适用
A Prospective, Multi-center, Non-Randomized, Single-arm, Open-label Study of Percutaneous Coronary Intervention in Community Hospitals Without Cardiac Surgery-On-Site
Baim Institute for Clinical Research10 个研究点 分布在 1 个国家目标入组 2,879 人开始时间: 2011年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,879
- 试验地点
- 10
- 主要终点
- Major Adverse Cardiac Event (MACE)
研究概览
简要总结
The primary objective of the Post-Randomization Phase Cohort Study is to continue to assess the safety of non-emergency PCI performed at hospitals without cardiac surgery on-site in patients with myocardial ischemia (other than ST-segment elevation myocardial infarction [STEMI]).
详细描述
The MASS COMM Post-Randomization Phase Cohort Study ("Cohort Study" is a prospective, multi-center, single-arm study of non-emergency PCI performed at non-SOS hospitals in patients with myocardial ischemia (other than STEMI). The Cohort Study is designed to allow non-SOS hospitals to continue to perform non-emergency PCI after enrollment to the MASS COMM trial is completed and before the 30-day and 12-month results are available.
Specifically, all eligible subjects, after enrollment to the MASS COMM randomized controlled trial is completed and before the final results are available and a decision is reached by the MA-DPH, will be consented and enrolled into this Cohort Study. Subjects will be followed through 30 days post procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Candidates for this study must meet ALL of the following criteria:
- •Subject is at least 18 years old.
- •Subject requires single- or multi-vessel percutaneous coronary intervention (PCI) of de novo or restenotic target lesion (including in-stent restenotic lesions). N.B. staged procedure will not be considered to meet the endpoint component of repeat revascularization if either of the following pre-catheterization procedure qualifying clinical laboratory values are met:
- •eGFR is less than 60 ml/min or
- •creatinine is greater than 1.5 mg/dl
- •Subject's lesion(s) is (are) amenable to stent treatment with currently available FDA-approved bare metal or drug eluting stents.
- •Subject is an acceptable candidate for non-emergency, urgent or emergency CABG.
- •Subject has clinical evidence of ischemic heart disease in terms of a positive functional study, or documented symptoms.
- •Documented stable angina pectoris [Canadian Cardiovascular Society Classification (CCS) 1, 2, 3, or 4], unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), non-ST segment elevation myocardial infarction, or documented silent ischemia.
- •Subject and the treating physician agree that the subject will comply with all follow-up evaluations.
- •Subject has been informed of the nature and purpose of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
- •Angiographic Inclusion Criteria
- •The target lesion(s) is (are) de novo or restenotic (including in-stent restenotic) native coronary artery lesion(s) with greater or equal to 50 and less than 100% stenosis (visual estimate), or the target lesion is an acute (less than 1 month) total occlusion as evidenced by clinical symptoms.
- •If Fractional Flow Reserve (FFR) is measured, target lesion(s) has (have) evidence of a hemodynamically significant stenosis determined by FFR measurement (FFR less than or equal to 0.8).
- •Target lesions(s) is (are) located in an infarct (if not treated with primary PCI) or non-infarct-related artery with a 70% or greater stenosis (by visual estimate) greater than 72 hours following the STEMI.
- •Lesions treated with PCI greater than 72 hours following STEMI would be subject to the same protocol inclusion/
排除标准
- •listed above and below with the exception that a target lesion of 70% or greater stenosis may be treated with or without symptoms or abnormal stress test).
- •Exclusion Criteria:
- •Subjects will be excluded from participation in the Cohort Study (and non-emergency PCI may not be performed in these patients at the non-SOS site) if ANY of the following conditions apply:
- •The patient is pregnant or breastfeeding.
- •Evidence of ST segment elevation myocardial infarction within 72 hours of the intended treatment on infarct related or non-infarct related artery.
- •Cardiogenic shock on presentation or during current hospitalization.
- •Left ventricular ejection fraction less than 20%.
- •Known allergies to: aspirin, clopidogrel (Plavix), prasugrel (Effient), and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent (which cannot be adequately premedicated).
- •A platelet count less than 75,000 cells/mm3 or greater than 700,000 cells/mm3 or a WBC less than 3,000 cells/mm
- •Acute or chronic renal dysfunction (creatinine less than 2.5 mg/dl or less than 150µmol/L).
- •Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).
- •Prior participation in the MASS-COMM Trial, unless the patient has completed the 12-month follow-up for the Trial, and/or prior participation in the Cohort Study, unless the patient has completed the 30-day follow-up for the Cohort Study.
- •Within 30 days prior to the index Cohort Study procedure, the subject has undergone a previous coronary interventional procedure of any kind. Note: This exclusion criterion does not apply to post-STEMI patients.
- •Stroke or transient ischemic attack within the prior 3 months.
- •Active peptic ulcer or upper GI bleeding within the prior 3 months.
- •Subject has active sepsis.
- •Unprotected left main coronary artery disease (stenosis greater than 50%).
- •Subject has evidence of a hemodynamically insignificant stenosis determined by FFR measurement (FFR greater than 0.8).
- •In the investigator's opinion, subject has a co-morbid condition(s) that could limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study.
- •Angiographic Exclusion Criteria
- •Subject has normal or insignificant coronaries (i.e., coronary lesion(s) less than 50% stenosis).
- •Any target vessel has evidence of:
- •excessive thrombus (e.g., requires target vessel thrombectomy)
- •tortuosity (greater than 60 degree angle) that makes it unsuitable for proper stent delivery and deployment,
- •heavy calcification.
- •Any target lesion requires treatment with a device other than PTCA prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
- •Any lesion that is located in a saphenous vein graft, however, lesions located within the native vessel but accessed through the graft are eligible.
- •The target vessel is in a "last remaining" epicardial vessel (e.g., >2 non-target epicardial vessels and the bypass grafts to these territories [if present] are totally occluded).
研究组 & 干预措施
Non-SOS
Other
干预措施: PCI (Procedure)
结局指标
主要结局
Major Adverse Cardiac Event (MACE)
时间窗: 30-days
MACE is a composite of all cause mortality, myocardial infarction (Q wave and non-Q wave), repeat coronary revascularization (of the target vessel or non-target vessel) by either percutaneous or coronary artery bypass graft (CABG) methods, or stroke, at 30-days.
次要结局
- All-Cause Mortality(30 days)
- Stroke(30 days)
- Revascularization(30 days)
- Major Vascular Complications(30 days)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
不适用
Safety of Oral Resin for Treatment of Hyperkalemia in Chinese Patients With Renal InsufficiencyHyperkalaemiaNCT05462119AstraZeneca887
招募中
不适用
A Prospective Cohort Study on Drug-induced Liver Injury in China（DILI-P）Drug-induced Liver InjuryNCT02961413Drug Induced Liver Disease Study Group10,000
进行中（未招募）
不适用
Safety and Effectiveness Evaluation of iCover Covered Stent for the Treatment of the Aorto-iliac Occlusive DiseaseAngioplastyIliac Artery DiseaseCovered StentAorto-Iliac AtherosclerosisPeripheral Arterial DiseaseNCT05192616iVascular S.L.U.241
已完成
不适用
CellFX System for the Treatment of Cutaneous Non-Genital WartsWartsWarts HandVerrucaNCT04554394Pulse Biosciences, Inc.62
进行中（未招募）
不适用
PREEMIE: Study for Treatment of PDA in Premature InfantsPatent Ductus Arteriosus (PDA)NCT06587282Merit Medical Systems, Inc.55