Delivery SSO2 Therapy for 60 Min in Anterior MI Patients With PCI ≤ 6 Hours of Symptoms Onset Compared to Standard.

NCT04743245 | Recruiting DMC FDA Device

• 1 other identifier: AMIHOT III 09 November 2021
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Myocardial Infarction; STEMI

Outcome Measures

Primary Outcomes (1)

• 1-year rate of Net Adverse Clinical Events (NACE)

  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)

  12 months

Secondary Outcomes (1)

• Difference in infarct size between SSO2 Therapy and standard therapy in patients

  At 2-7 days and at 6 month

Study Arms (2)

PCI with SSO2 therapy

EXPERIMENTAL

AMI subjects treated with SSO2 Therapy following PCI with stenting

Device: TherOx DownStream System; Device: PCI

anterior AMI patients treated with PCI and stenting within 6 hours

ACTIVE COMPARATOR

Control group receiving PCI with stenting alone

Device: PCI

Interventions

TherOx DownStream System DEVICE

SSO2 Therapy with Therox downstream System after Percutaneous Coronary Intervention (PCI)

PCI with SSO2 therapy

PCI DEVICE

Standard Care of PCI

PCI with SSO2 therapy; anterior AMI patients treated with PCI and stenting within 6 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre-PCI:
• The subject must be ≥18 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).
• 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).
• 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).
• 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.
• 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.
• 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).

You may not qualify if:

• Patients will be excluded if ANY of the following conditions apply:
• Pre-PCI:
• Prior CABG surgery.
• Prior myocardial infarction or known prior systolic dysfunction (e.g. due to cardiomyopathy); this criterion does not include left ventricular dysfunction induced by the acute MI.
• An elective surgical procedure is planned 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.
• Contraindication to MRI imaging, including any of the following:
• Non-MRI compatible cardiac pacemaker or implantable defibrillator;
• Non-MRI compatible aneurysm clip or other metallic implants;
• 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 indwelling metallic foreign body, shrapnel, or bullet;

Sponsors & Collaborators

• TherOx: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• James Blankenship, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Gregg Stone, MD

  MOUNT SINAI HOSPITAL

  STUDY CHAIR

• Amir S Lotfi, MD

  Baystate Health

  STUDY DIRECTOR

Central Study Contacts

Jeffrey Creech, PhD

CONTACT

3233096949; jcreech@zoll.com

Shailaja Lakma

CONTACT

9253367743; slakma@zoll.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 8, 2021
• Study Start: August 2, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)