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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05949515
Other study ID # RESCU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 31, 2023
Est. completion date March 31, 2024

Study information

Verified date April 2024
Source Cardiovascular Research Foundation, New York
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this multicenter study is to assess the impact of SSO2 treatment on clinical outcomes and left ventricular function in patients following acute ST-segment elevation myocardial infarction (STEMI).


Description:

The TherOx® Downstream® System, which is approved for use in the United States (US) by the Food and Drug Administration (FDA) under P170027. The TherOx® Downstream® System consists of three primary components. These include a hardware device called the TherOx Downstream System ("console"), a single-use disposable device called the TherOx Downstream Cartridge ("cartridge") and a 5 French, commercially available qualified SSO2 infusion coronary delivery catheter ("delivery catheter"). This is a multicenter, retrospective case-control study which will collect data from all STEMI patients who received SSO2 treatment at participating centers, along with up to 3 matched control patients who did not receive SSO2 treatment.


Recruitment information / eligibility

Status Completed
Enrollment 403
Est. completion date March 31, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Data from all patients who received SSO2 treatment and have completed a minimum of 3 months follow up will be collected at each participating center; there are no other exclusion criteria aside from date of treatment. Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States OhioHealth Research Institute Columbus Ohio
United States Oakwood Healthcare, Inc Dearborn Michigan
United States Avita Health Galion Ohio
United States Northwell Health, Inc Great Neck New York
United States St. Mary's Medical Center Huntington West Virginia
United States Baptist Hospital of Miami, Inc and Its Miami Cardiac and Vascular Institute Miami Florida
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota
United States NCH Healthcare System Naples Florida

Sponsors (1)

Lead Sponsor Collaborator
Cardiovascular Research Foundation, New York

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Left Ventricular Ejection Fraction Between group comparison Baseline to 3 months
Primary Rate of Cardiovascular related Hospitalizations Between group comparison Through study completion, an average of 1 year
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