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[未经美国FDA批准或批准的设备试用]

2026年5月20日 更新者:TherOx
The purpose of this study is to evaluate the feasibility of the delivery of SuperSaturated Oxygen (SSO2) Therapy for 60 minutes selectively into the left main coronary artery (LMCA). The therapy will be delivered with a commercially available qualified SSO2 delivery catheter used with the TherOx® DownStream® System and Cartridge in the treatment of patients presenting with an anterior acute myocardial infarction (heart attack) ≤ six hours after symptom onset with successful reperfusion (via PCI).

研究概览

研究类型

介入性

注册 (实际的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Arizona
      • Scottsdale、Arizona、美国、85259
        • Scottsdale Healthcare
    • Michigan
      • Royal Oak、Michigan、美国、48703
        • Beaumont Hospital, Royal Oak
      • Southfield、Michigan、美国、48075
        • Providence Hospital and Medical Centers
    • Tennessee
      • Kingsport、Tennessee、美国、37660
        • Wellmont Holston Valley Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

GENERAL INCLUSION CRITERIA: Candidates for this study must meet ALL of the following criteria:

Pre-PCI:

  1. The subject must be ≥18 and ≤80 years of age.
  2. AMI must be anterior.
  3. Subject is experiencing clinical symptoms consistent with anterior AMI of ≤6 hour duration.
  4. Signed Informed Consent.
  5. Subject agrees to all required follow-up procedures and visits.
  6. Negative pregnancy test for women of childbearing potential.

    ANGIOGRAPHIC INCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent but prior to enrollment:

  7. PCI is indicated for revascularization of the culprit lesion(s) with use of a commercially available coronary stent in the LAD.
  8. The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery.
  9. Baseline (pre-PCI) TIMI flow grade 0, 1, 2, or 3 flow in the LAD.
  10. Successful angioplasty and no major complications such as perforation or shock.
  11. Expected ability to place the SSO2 delivery catheter in the coronary ostium of the left main coronary system to deliver SSO2 Therapy with stable, coaxial alignment.
  12. Planned revascularization of a non-target lesion is allowed.

    Patients will be excluded if ANY of the following conditions apply:

    GENERAL EXCLUSION CRITERIA

    Pre-PCI:

  13. Prior CABG surgery.
  14. Prior myocardial infarction, or known prior systolic dysfunction.
  15. Thrombolytic therapy administered for this STEMI.
  16. An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first 30 days post-enrollment.
  17. Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the anterior AMI.
  18. Subjects who have previously undergone angioplasty or stenting in the LAD.
  19. Subjects with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation.
  20. Any contraindication to undergo MRI imaging.
  21. Impaired renal function or on dialysis.
  22. Known platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a known Hgb <10 g/dL.
  23. Subject has active bleeding or a history of bleeding.
  24. History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke.
  25. Stroke or transient ischemic attack within the past six (6) months, or any permanent neurological defect.
  26. Gastrointestinal or genitourinary bleeding within the last two (2) months, or any major surgery (including CABG) within six weeks of enrollment.
  27. Subject has received any organ transplant or is on a waiting list for any organ transplant.
  28. Subject has other medical illness (e.g., cancer, dementia) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that a may cause non-compliance with the protocol.
  29. Subject has a known hypersensitivity or contraindication to unfractionated heparin, abciximab, aspirin, bivalirudin, clopidogrel, ticlopidine, prasugrel, or ticagrelor that cannot be adequately premeditated.
  30. Current use of warfarin, dabigatran, or factor Xa inhibitors.
  31. Subjects presenting with or developing in the cath lab: cardiogenic shock or ventricular fibrillation or tachycardia.
  32. Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or non-ischemic cardiomyopathy.
  33. Any significant medical condition which in the investigator's opinion may interfere with the subject's optimal participation in the study.
  34. Current participation in other investigational device or drug trials that have not finished the primary endpoint follow-up period.
  35. Previous enrollment in this study.

    ANGIOGRAPHIC EXCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent but prior to enrollment:

  36. Inability to achieve a stable coaxial position in the left main coronary artery with the catheter.
  37. Treatment during the index procedure of any lesion in the left main, LCX, and/or RCA.
  38. Coronary anatomy such that coronary artery bypass graft surgery is indicated within 30 days.
  39. Post-index procedure planned intervention within 30 days.
  40. Anatomic features are present which are highly unfavorable for PCI.
  41. Anterior MI is due to thrombosis within or adjacent to a previously implanted stent.
  42. Left ventriculography demonstrates severe mitral regurgitation, a ventricular septal defect, or a pseudoaneurysm.
  43. Any left main coronary artery stenosis >20%.
  44. Any untreated LAD or diagonal branch lesion is present with diameter stenosis >= 50% in a vessel with reference vessel diameter > 2.0 mm or for which PCI will be required before the MRI study.
  45. Presence of a non-stented coronary dissection upon completion of the PCI procedure.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Optimized SSO2 Therapy
Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The Feasibility of Intracoronary Infusion of SSO2 Therapy
大体时间:Procedure
Successful administration of SSO2 Therapy (60 minutes) without dislodgment of the SSO2 delivery catheter during the infusion and without untoward Serious Adverse Events
Procedure

次要结果测量

结果测量
措施说明
大体时间
Median Myocardial Salvage Index
大体时间:3 to 5 days post-procedure
Myocardial Salvage Index by cardiac MRI at 3-5 days post-procedure, read by an independent MRI core laboratory. Calculated as (1 - infarct mass / area at risk) × 100, with both quantified in grams of left ventricular myocardium. Range 0% (no salvage, entire area at risk infarcted) to 100% (no infarction within the area at risk). Higher values are better.
3 to 5 days post-procedure
Median Infarct Size by Cardiac MRI
大体时间:3 to 5 days post-procedure
Infarct size by cardiac MRI with late gadolinium enhancement at 3-5 days post-procedure, read by an independent MRI core laboratory. Calculated as infarct mass divided by total left ventricular mass, expressed as a percentage. Range 0% to 100%. Lower values are better.
3 to 5 days post-procedure
Median Infarct Size by Cardiac MRI
大体时间:30 days post-procedure
Infarct size by cardiac MRI with late gadolinium enhancement at 30 (±7) days post-procedure, read by an independent MRI core laboratory. Calculated as infarct mass divided by total left ventricular mass, expressed as a percentage. Range 0% to 100%. Lower values are better.
30 days post-procedure
MACE - CEC Adjudicated
大体时间:30 days post-procedure
cardiac death, reinfarction or ischemia-driven TLR
30 days post-procedure
Target Vessel Failure (TVF) - CEC Adjudicated
大体时间:30 days post-procedure
all-cause death, reinfarction or ischemia-driven TVR
30 days post-procedure
Cardiac Death - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Vascular Death - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Non-Cardiovascular Death
大体时间:30 days post-procedure
30 days post-procedure
New-Onset Heart Failure - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Heart Failure Requiring Hospitalization - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Re-Hospitalization for Previous Heart Failure - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Myocardial Infarction - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Myocardial Infarction, Spontaneous - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Myocardial Infarction, Periprocedural (PCI) - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Myocardial Infarction, Periprocedural (CABG) - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Myocardial Infarction, STEMI - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Myocardial Infarction, NSTEMI - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Repeat Angiography/Revascularization - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Clinically Driven Target Lesion Revascularization (TLR) - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Clinically Driven Target Vessel Revascularization (TVR) - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Stent Thrombosis (ARC Criteria) - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Definite Stent Thrombosis (ARC Criteria) - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Probable Stent Thrombosis (ARC Criteria) - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Possible Stent Thrombosis (ARC Criteria) - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Neurologic Event (Stroke, TIA) - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure
Hemorrhagic/Vascular Event - CEC Adjudicated
大体时间:30 days post-procedure
30 days post-procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Gregg W Stone, M.D.、Columbia University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年8月1日

初级完成 (实际的)

2013年9月1日

研究完成 (实际的)

2014年8月1日

研究注册日期

首次提交

2012年6月26日

首先提交符合 QC 标准的

2012年6月27日

首次发布 (估计的)

2012年6月28日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月20日

最后验证

2026年5月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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