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[Teste do dispositivo que não é aprovado ou liberado pelo FDA dos EUA]

20 de maio de 2026 atualizado por: 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).

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Real)

20

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The Feasibility of Intracoronary Infusion of SSO2 Therapy
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Median Myocardial Salvage Index
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 30 days post-procedure
cardiac death, reinfarction or ischemia-driven TLR
30 days post-procedure
Target Vessel Failure (TVF) - CEC Adjudicated
Prazo: 30 days post-procedure
all-cause death, reinfarction or ischemia-driven TVR
30 days post-procedure
Cardiac Death - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Vascular Death - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Non-Cardiovascular Death
Prazo: 30 days post-procedure
30 days post-procedure
New-Onset Heart Failure - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Heart Failure Requiring Hospitalization - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Re-Hospitalization for Previous Heart Failure - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Myocardial Infarction - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Myocardial Infarction, Spontaneous - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Myocardial Infarction, Periprocedural (PCI) - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Myocardial Infarction, Periprocedural (CABG) - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Myocardial Infarction, STEMI - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Myocardial Infarction, NSTEMI - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Repeat Angiography/Revascularization - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Clinically Driven Target Lesion Revascularization (TLR) - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Clinically Driven Target Vessel Revascularization (TVR) - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Stent Thrombosis (ARC Criteria) - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Definite Stent Thrombosis (ARC Criteria) - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Probable Stent Thrombosis (ARC Criteria) - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Possible Stent Thrombosis (ARC Criteria) - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Neurologic Event (Stroke, TIA) - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure
Hemorrhagic/Vascular Event - CEC Adjudicated
Prazo: 30 days post-procedure
30 days post-procedure

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Gregg W Stone, M.D., Columbia University

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de agosto de 2012

Conclusão Primária (Real)

1 de setembro de 2013

Conclusão do estudo (Real)

1 de agosto de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

26 de junho de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de junho de 2012

Primeira postagem (Estimado)

28 de junho de 2012

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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