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

NCT01630707 | Completed Results DMC FDA Device

• 1 other identifier: IDE G120029
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Anterior Wall Acute Myocardial Infarction

Keywords

SSO2 Therapy; acute myocardial infarction; anterior myocardial infarction; SuperSaturated oxygen delivery; left main coronary artery; myocardial infarction; heart attack; percutaneous coronary intervention; cardiac catheterization laboratory; PCI; stent; stenting; stents; angioplasty; LMCA; Delivery of supersaturated oxygen (SSO2) therapy for the treatment of anterior acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (26)

• Median Myocardial Salvage Index

  3 to 5 days post-procedure

• Median Infarct Size by Cardiac MRI

  3 to 5 days post-procedure

• Median Infarct Size by Cardiac MRI

  30 days post-procedure

• MACE - CEC Adjudicated

  30 days post-procedure

• Target Vessel Failure (TVF) - CEC Adjudicated

  30 days post-procedure

Study Arms (1)

Optimized SSO2 Therapy

EXPERIMENTAL

Device: SuperSaturated Oxygen (SS02) Therapy

Interventions

SuperSaturated Oxygen (SS02) Therapy DEVICE

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

Optimized SSO2 Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre-PCI:
• The subject must be ≥18 and ≤80 years of age.
• AMI must be anterior.
• Subject is experiencing clinical symptoms consistent with anterior AMI of ≤6 hour duration.
• Signed Informed Consent.
• Subject agrees to all required follow-up procedures and visits.
• Negative pregnancy test for women of childbearing potential.
• PCI is indicated for revascularization of the culprit lesion(s) with use of a commercially available coronary stent in the LAD.
• The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery.
• Baseline (pre-PCI) TIMI flow grade 0, 1, 2, or 3 flow in the LAD.
• Successful angioplasty and no major complications such as perforation or shock.
• 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.
• Planned revascularization of a non-target lesion is allowed.
• Patients will be excluded if ANY of the following conditions apply:

You may not qualify if:

• Pre-PCI:
• Prior CABG surgery.
• Prior myocardial infarction, or known prior systolic dysfunction.
• Thrombolytic therapy administered for this STEMI.
• An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first 30 days post-enrollment.
• Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the anterior AMI.
• Subjects who have previously undergone angioplasty or stenting in the LAD.
• Subjects with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation.
• Any contraindication to undergo MRI imaging.
• Impaired renal function or on dialysis.
• Known platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a known Hgb \<10 g/dL.
• Subject has active bleeding or a history of bleeding.
• History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke.
• Stroke or transient ischemic attack within the past six (6) months, or any permanent neurological defect.
• Gastrointestinal or genitourinary bleeding within the last two (2) months, or any major surgery (including CABG) within six weeks of enrollment.

Sponsors & Collaborators

• TherOx: lead

Study Sites (4)

Scottsdale Healthcare

Scottsdale, Arizona, 85259, United States

Location

Beaumont Hospital, Royal Oak

Royal Oak, Michigan, 48703, United States

Location

Providence Hospital and Medical Centers

Southfield, Michigan, 48075, United States

Location

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37660, United States

Location

Related Publications (3)

• 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.

  PMID: 19733713 BACKGROUND

• 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.

  PMID: 20031745 BACKGROUND

• 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.

  PMID: 15979426 BACKGROUND

MeSH Terms

Conditions

Anterior Wall Myocardial Infarction; Myocardial Infarction

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Gregg W. Stone MD
• Organization: Columbia University Medical Center, The Cardiovascular Research Foundation

gs2184@columbia.edu

646-434-4134

Study Officials

• Gregg W Stone, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: August 1, 2014
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-05

Locations

US (4)