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NCT04743245 · ClinicalTrials.gov registry record · NA
Delivery SSO2 Therapy for 60 Min in Anterior MI Patients With PCI ≤ 6 Hours of Symptoms Onset Compared to Standard.
A NA study of Acute Myocardial Infarction and STEMI, sponsored by TherOx.
- Recruiting
- Registry status
- NA
- Development phase
- 434
- Enrollment target
- 1
- Study location
NCT04743245: Recruiting NA study of Acute Myocardial Infarction and STEMI, sponsored by TherOx.
NCT04743245 is a NA study of Acute Myocardial Infarction and STEMI that is actively recruiting participants, run by TherOx. The registered enrollment target is 434 participants, below the 1,859-participant average among 19 other Acute Myocardial Infarction trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04743245, a NA study of Acute Myocardial Infarction and STEMI, is actively recruiting participants, sponsored by TherOx.
- RECRUITING
- Registry status
- NA
- Development phase
- 434 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
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)
Conditions Studied
Interventions
- DEVICE TherOx DownStream System
- DEVICE PCI
Study Locations (1)
Massachusetts
- Baystate Medical Center - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 434 participants |
| Start Date | 2022-08-02 |
| Est. Completion | 2026-04-30 |
| Phase | NA |
What NCT04743245 shows while recruiting
NCT04743245 is an interventional study that assigns participants to a tested intervention. The registered 434 participants enrollment target is mid-sized for trials with a published cap, below the 1,859-participant average among 19 other Acute Myocardial Infarction trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with Acute Myocardial Infarction appearing as the primary indexed condition, and to 2 interventions - of which TherOx DownStream System is the first listed.
NCT04743245 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04743245 about?
NCT04743245 is a clinical study titled "Delivery SSO2 Therapy for 60 Min in Anterior MI Patients With PCI ≤ 6 Hours of Symptoms Onset Compared to Standard.". 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
What is the current status of trial NCT04743245?
This trial is currently recruiting. It is a NA study. The enrollment target is 434 participants. The study started on 2022-08-02. Estimated completion is 2026-04-30.
What conditions does trial NCT04743245 study?
This clinical trial studies the following conditions: Acute Myocardial Infarction, STEMI.
What interventions are being tested in trial NCT04743245?
The interventions under investigation include: TherOx DownStream System (DEVICE), PCI (DEVICE).
Who is sponsoring clinical trial NCT04743245?
This trial is sponsored by TherOx, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04743245 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04743245's enrollment target sits among peer trials
434 11th of 19 higher than 9 of 19 other Acute Myocardial Infarction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myocardial Infarction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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