Trials / Withdrawn
WithdrawnNCT04876040
Incorporating Supersaturated Oxygen in Shock
A Multi-Center Randomized-Controlled Trial To Evaluate The Safety And Feasibility of The Delivery Of Intracoronary Hyperoxemic Supersaturated Oxygen Therapy For 60 Minutes In Patients With St Elevation Myocardial Infarction (STEMI) And Cardiogenic Shock After Successful Reperfusion (Via PCI) ≤ Six Hours After Symptom Onset Compared To Standard Therapy
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- TherOx · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A multi-center, prospective randomized (1:1) pilot and feasibility study to evaluate the safety and feasibility of supersaturated oxygen (SSO2) therapy delivered for 60 minutes selectively into the culprit coronary artery of patients presenting with ST elevation myocardial infarction and cardiogenic shock (STEMI-CS) treated using a shock protocol.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SSO2 Downstream System | 60-min adjunctive reperfusion of hyperoxemic blood into target coronary artery, immediately following revascularization by means of PCI with stenting. |
| PROCEDURE | PCI + Impella | Standard of Care Intervention |
Timeline
- Start date
- 2021-12-17
- Primary completion
- 2024-01-17
- Completion
- 2025-06-01
- First posted
- 2021-05-06
- Last updated
- 2024-01-24
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04876040. Inclusion in this directory is not an endorsement.