NCT02603835

Brief Summary

The primary objective of the study is to collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in treatment of anterior acute myocardial infarction (AMI) patients who have undergone successful percutaneous coronary intervention (PCI) with stenting within six hours of experiencing AMI symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2018

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

September 15, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

November 10, 2015

Results QC Date

August 9, 2022

Last Update Submit

September 12, 2023

Conditions

Anterior Wall Acute Myocardial Infarction

Keywords

SSO2 TherapyAcute myocardial infarctionAnterior myocardial infarctionSuperSaturated oxygen deliveryLeft main coronary arteryMyocardial infarctionHeart attackPercutaneous coronary interventionCardiac catheterization laboratoryPCIStentStentingStentsAngioplastyLMCADelivery of supersaturated oxygen (SSO2) therapy for the treatment of anterior acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Rate of Net Adverse Clinical Events (NACE)

    Composite of death, reinfarction, clinically-driven target vessel revascularization, stent thrombosis (ARC definite or probable), new onset severe heart failure or readmission for heart failure, and TIMI major or minor bleeding. This outcome measure includes a hierarchical sum of the events, meaning if a subject experiences two event types they are only counted once in the overall NACE rate.

    30-Day

Secondary Outcomes (5)

  • Rate of Target Lesion Failure

    30 days

  • Rate of Net Adverse Clinical Events (NACE)

    1 year

  • Target Lesion Failure

    1 year

  • Median Infarct Size by Cardiac MRI

    30 days

  • Microvascular Obstruction by Cardiac MRI

    4 days post-procedure

Study Arms (1)

SSO2 Therapy

EXPERIMENTAL

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

Device: SSO2 Therapy

Interventions

SSO2 TherapyDEVICE

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

Also known as: TherOx DownStream System, TherOx DownStream Cartridge, SSO2 Delivery Catheter
SSO2 Therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 (ST-segment elevation \>1 mm in two or more contiguous leads between V1 and V4 or new left bundle branch block).
  • Subject is experiencing clinical symptoms consistent with anterior AMI of ≤6 hour duration from time of symptom onset until admission to the emergency room.
  • The subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB).
  • Subject and his/her physician agree to all required follow-up procedures and visits.
  • Based on coronary anatomy, PCI is indicated for revascularization of the culprit lesion(s) with use of a commercially available coronary stent (bare metal or drug-eluting, at operator discretion) in the LAD.
  • The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery (other lesions in the LAD target vessel, including diagonal branches, may be treated if clinically indicated).
  • Baseline (pre-PCI) TIMI flow grade 0, 1, 2, or 3 flow in the LAD.
  • Successful angioplasty as documented by \<50% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow 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.

You may not qualify if:

  • Pre-PCI:
  • Prior CABG surgery.
  • Prior myocardial infarction, or known prior systolic dysfunction (known ejection fraction \<40% by any prior measure or regional wall motion abnormalities; this criterion does not include left ventricular dysfunction induced by the acute MI).
  • 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 an angioplasty or stenting procedure in the left anterior descending coronary artery.
  • Subjects with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation (with or without papillary muscle rupture).
  • Cardiac pacemaker or implantable defibrillator;
  • Non-MRI compatible aneurysm clip;
  • Neural Stimulator (i.e., TENS unit);
  • Any implanted or magnetically activated device (insulin pump);
  • Any type of non-MRI compatible ear implant;
  • Metal shavings in the orbits;
  • Any metallic foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject;
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Heart Center, Inc.

Huntsville, Alabama, 35801, United States

Location

Scripps Hospital

La Jolla, California, 92037, United States

Location

Danbury Hospital

Danbury, Connecticut, 06801, United States

Location

Alexian Brothers Heart & Vascular Institute

Elk Grove Village, Illinois, 60007, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

St. John Hospital & Medical Center

Detroit, Michigan, 48236, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Providence-Providence Park Hospital

Southfield, Michigan, 48075, United States

Location

WakeMed Heart Center

Raleigh, North Carolina, 27610, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18101, United States

Location

Holy Spirit Cardiology

Camp Hill, Pennsylvania, 17011, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

The Miriam Hospital/Rhode Island Hospital

Providence, Rhode Island, 02906, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Related Publications (1)

  • Chen S, David SW, Khan ZA, Metzger DC, Wasserman HS, Lotfi AS, Hanson ID, Dixon SR, LaLonde TA, Genereux P, Ozan MO, Maehara A, Stone GW. One-year outcomes of supersaturated oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2021 May 1;97(6):1120-1126. doi: 10.1002/ccd.29090. Epub 2020 Jul 10.

    PMID: 32649037DERIVED

MeSH Terms

Conditions

Anterior Wall Myocardial InfarctionMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Results Point of Contact

Title
Jeffrey L. Creech, Ph.D.
Organization
TherOx, Inc.
jcreech@therox.com
(949) 225-6587

Study Officials

  • Gregg W. Stone, MD

    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

November 10, 2015

First Posted

November 13, 2015

Study Start

February 1, 2016

Primary Completion

August 1, 2017

Study Completion

May 17, 2018

Last Updated

September 15, 2023

Results First Posted

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(15)