Acute Myocardial Infarction, STEMI
Conditions
Brief summary
A multi-center randomized post-approval evaluation of delivery of intracoronary hyperoxemic supersaturated Oxygen therapy for 60 minutes in anterior AMI patients with successful reperfusion (via PCI) within 6 hours after onset of symptoms compared to standard therapy
Detailed description
This is a prospective, open-label, randomized (1:1) study. Subjects who present with anterior STEMI requiring stent placement in the proximal and/or mid LAD who meet all inclusion and exclusion criteria and provide informed consent will be treated with PCI with stenting, and if successful and uncomplicated then immediately randomized to post-procedure infusion of SSO2 Therapy for a duration of 60 minutes or standard of care.
Interventions
DEVICETherOx DownStream System
SSO2 Therapy with Therox downstream System after Percutaneous Coronary Intervention (PCI)
DEVICEPCI
Standard Care of PCI
Sponsors
TherOx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Pre-PCI: 1. The subject must be ≥18 years of age. 2. 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). 3. 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) or Ethics Committee (EC). 4. Subject and his/her physician agree to all required follow-up procedures and visits. ANGIOGRAPHIC INCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent and has undergone cardiac catheterization and PCI if indicated: 5. 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. 6. 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). 7. Successful angioplasty is completed \<6 hrs from symptom onset, as documented by 30% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow and no major complications such as perforation or shock. 8. 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. 9. Systemic arterial pO2 greater than or equal to 80 mmHg as measured by arterial blood gas (may be repeated if low after supplemental O2 administration).
Exclusion criteria
\- Patients will be excluded if ANY of the following conditions apply: GENERAL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year rate of Net Adverse Clinical Events (NACE) | 12 months | The composite NACE endpoint includes a hierarchical total of the following events: * Death (all-cause) * Reinfarction * Target Vessel Revascularization (ischemia-driven) * TIMI major or minor bleeding * New onset heart failure or re-hospitalization for heart failure * Stent thrombosis (ARC definite or probable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in infarct size between SSO2 Therapy and standard therapy in patients | At 2-7 days and at 6 month | Change from 2-7 days to 6 months in MRI endpoints |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJames Blankenship, MD
University of New Mexico
STUDY_CHAIRGregg Stone, MD
MOUNT SINAI HOSPITAL
STUDY_DIRECTORAmir S Lotfi, MD
Baystate Health
Outcome results
None listed