Trials / Terminated
TerminatedNCT05156996
A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 Therapy Using the TherOx® Downstream® System
A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 Therapy Using the TherOx® Downstream® System After PCI vs. PCI Alone Among Patients Undergoing PCI for Acute Anterior Myocardial Infarction
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 6 (actual)
- Sponsor
- TherOx · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to collect real-world data on the TherOx DownStream System® to assess the effectiveness and cost- effectiveness of SSO2 Therapy, compared with PCI alone for treatment of patients with acute anterior MI.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Supersaturated O2 Therapy of the Therox Downstream System® | SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient's left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion. |
| PROCEDURE | PCI alone | Percutaneous Coronary Intervention for treatment of acute MI |
Timeline
- Start date
- 2022-12-04
- Primary completion
- 2024-01-04
- Completion
- 2024-04-24
- First posted
- 2021-12-14
- Last updated
- 2024-05-17
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05156996. Inclusion in this directory is not an endorsement.