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[Prueba de dispositivo que no está aprobado o aprobado por la FDA de EE. UU.]

20 de mayo de 2026 actualizado 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).

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

20

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • 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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The Feasibility of Intracoronary Infusion of SSO2 Therapy
Periodo de tiempo: 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 resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2012

Finalización primaria (Actual)

1 de septiembre de 2013

Finalización del estudio (Actual)

1 de agosto de 2014

Fechas de registro del estudio

Enviado por primera vez

26 de junio de 2012

Primero enviado que cumplió con los criterios de control de calidad

27 de junio de 2012

Publicado por primera vez (Estimado)

28 de junio de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

20 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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