Evaluation of the Delivery of Optimized Supersaturated Ox... | NCT01630707

Label	Type	Description	Intervention Names
Optimized SSO2 Therapy	Experimental		Device: SuperSaturated Oxygen (SS02) Therapy

Name	Type	Description	Arm Group Labels	Other Names
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

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

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

Eligibility Module

Eligibility Criteria

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

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.

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

GENERAL EXCLUSION CRITERIA

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.
Subject has received any organ transplant or is on a waiting list for any organ transplant.
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.
Subject has a known hypersensitivity or contraindication to unfractionated heparin, abciximab, aspirin, bivalirudin, clopidogrel, ticlopidine, prasugrel, or ticagrelor that cannot be adequately premeditated.
Current use of warfarin, dabigatran, or factor Xa inhibitors.
Subjects presenting with or developing in the cath lab: cardiogenic shock or ventricular fibrillation or tachycardia.
Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or non-ischemic cardiomyopathy.
Any significant medical condition which in the investigator's opinion may interfere with the subject's optimal participation in the study.
Current participation in other investigational device or drug trials that have not finished the primary endpoint follow-up period.
Previous enrollment in this study.

ANGIOGRAPHIC EXCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent but prior to enrollment:
Inability to achieve a stable coaxial position in the left main coronary artery with the catheter.
Treatment during the index procedure of any lesion in the left main, LCX, and/or RCA.
Coronary anatomy such that coronary artery bypass graft surgery is indicated within 30 days.
Post-index procedure planned intervention within 30 days.
Anatomic features are present which are highly unfavorable for PCI.
Anterior MI is due to thrombosis within or adjacent to a previously implanted stent.
Left ventriculography demonstrates severe mitral regurgitation, a ventricular septal defect, or a pseudoaneurysm.
Any left main coronary artery stenosis >20%.
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.
Presence of a non-stented coronary dissection upon completion of the PCI procedure.

Name	Affiliation	Role
Gregg W Stone, M.D.	Columbia University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Scottsdale Healthcare		Scottsdale	Arizona	85259	United States
Beaumont Hospital, Royal Oak

PubMed Identifier	Type	Citation	Retractions
19733713	Background	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.
20031745	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.

ID	Title	Description
FG000	Optimized SSO2 Therapy	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

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Posted

Number

participants

Procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Title

Denominators

Categories

Title	Measurements
	OG00020

Secondary

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.

Cardiac MRI was attempted in all 20 subjects, but evaluable data were not available for every subject at every time point. Missing or non-evaluable scans could reflect scans not reported, technical or core-lab issues, or patient inability to tolerate the procedure (for example, claustrophobia). The specific cause per subject is not known. The analysis includes all subjects with evaluable data at each time point.

Posted

Median

Inter-Quartile Range

percentage

3 to 5 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants

Secondary

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.

Posted

Median

Inter-Quartile Range

percentage

3 to 5 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants

Secondary

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.

Posted

Median

Inter-Quartile Range

percentage

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants

Secondary

MACE - CEC Adjudicated

cardiac death, reinfarction or ischemia-driven TLR

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Target Vessel Failure (TVF) - CEC Adjudicated

all-cause death, reinfarction or ischemia-driven TVR

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Cardiac Death - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Vascular Death - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Non-Cardiovascular Death

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

New-Onset Heart Failure - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Heart Failure Requiring Hospitalization - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Re-Hospitalization for Previous Heart Failure - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Myocardial Infarction - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Myocardial Infarction, Spontaneous - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Myocardial Infarction, Periprocedural (PCI) - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Myocardial Infarction, Periprocedural (CABG) - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Myocardial Infarction, STEMI - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Myocardial Infarction, NSTEMI - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Repeat Angiography/Revascularization - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Clinically Driven Target Lesion Revascularization (TLR) - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Clinically Driven Target Vessel Revascularization (TVR) - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Stent Thrombosis (ARC Criteria) - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Definite Stent Thrombosis (ARC Criteria) - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Probable Stent Thrombosis (ARC Criteria) - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Possible Stent Thrombosis (ARC Criteria) - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Neurologic Event (Stroke, TIA) - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Secondary

Hemorrhagic/Vascular Event - CEC Adjudicated

Posted

Number

participants

30 days post-procedure

ID	Title	Description
OG000	Optimized SSO2 Therapy	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

Units	Counts
Participants	OG00020

Term	Organ System	Assessment Type	Statistical Information
Stent thrombosis	Cardiac disorders	Systematic Assessment	EG0001 affected20 at risk
Reinfarction	Cardiac disorders	Systematic Assessment	EG0001 affected20 at risk
Heart failure	Cardiac disorders	Systematic Assessment	EG0001 affected20 at risk

ID	Term
D056988	Anterior Wall Myocardial Infarction
D009203	Myocardial Infarction

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis