Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack

MultiCenter Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy in Patients With Anterior Acute Myocardial Infarction ≤ Six Hours After Symptom Onset and Successful Reperfusion (Via PCI)

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).

Study Overview

• Status: Completed
• Conditions: Anterior Wall Acute Myocardial Infarction
• Intervention / Treatment: Device: SuperSaturated Oxygen (SS02) Therapy

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optimized SSO2 Therapy	Device: SuperSaturated Oxygen (SS02) 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Feasibility of Intracoronary Infusion of SSO2 Therapy	Successful administration of SSO2 Therapy (60 minutes) without dislodgment of the SSO2 delivery catheter during the infusion and without untoward Serious Adverse Events	Procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: TherOx
• Investigators: Principal Investigator: Gregg W Stone, M.D., Columbia University

Publications and helpful links

General Publications

• Stone GW, Martin JL, de Boer MJ, Margheri M, Bramucci E, Blankenship JC, Metzger DC, Gibbons RJ, Lindsay BS, Weiner BH, Lansky AJ, Krucoff MW, Fahy M, Boscardin WJ; AMIHOT-II Trial Investigators. Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction. Circ Cardiovasc Interv. 2009 Oct;2(5):366-75. doi: 10.1161/CIRCINTERVENTIONS.108.840066. Epub 2009 Sep 15.
• Friedewald VE, Gibbons RJ, O'Neill WW, Popma JJ, Stone GW, Roberts WC. The editor's roundtable: intracoronary hyperoxemic therapy in acute myocardial infarction. Am J Cardiol. 2009 Sep 15;104(6):791-7. doi: 10.1016/j.amjcard.2009.06.018. No abstract available.
• Warda HM, Bax JJ, Bosch JG, Atsma DE, Jukema JW, van der Wall EE, van der Laarse A, Schalij MJ, Oemrawsingh PV. Effect of intracoronary aqueous oxygen on left ventricular remodeling after anterior wall ST-elevation acute myocardial infarction. Am J Cardiol. 2005 Jul 1;96(1):22-4. doi: 10.1016/j.amjcard.2005.02.037.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: June 26, 2012
• First Submitted That Met QC Criteria: June 27, 2012
• First Posted (Estimated): June 28, 2012

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: PCI; percutaneous coronary intervention; myocardial infarction; stent; stenting; stents; acute myocardial infarction; angioplasty; heart attack; SSO2 Therapy; SuperSaturated oxygen delivery; LMCA; Delivery of supersaturated oxygen (SSO2) therapy for the treatment of anterior acute myocardial infarction; cardiac catheterization laboratory; left main coronary artery; anterior myocardial infarction
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Anterior Wall Myocardial Infarction; Therapeutics
• Other Study ID Numbers: IDE G120029

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes