CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
SSO2 Therapydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02603835
NCT02603835N/ACompleted
CompareCT.gov

A Multi-Center Evaluation of the Delivery of Intracoronary Hyperoxemic Supersaturated Oxygen Therapy for 60 Minutes in Anterior Acute Myocardial Infarction Patients With Successful Reperfusion (Via PCI) ≤ Six Hours After Symptom Onset

TherOx·interventional·Posted Nov 13, 2015·Updated Sep 15, 2023

In Brief

A clinical study evaluating SSO2 Therapy for Anterior Wall Acute Myocardial Infarction. Completed, enrolled 100 participants across 15 sites.

Detailed Summary

The primary objective of the study is to collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in treatment of anterior acute myocardial infarction (AMI) patients who have undergone successful percutaneous coronary intervention (PCI) with stenting within six hours of experiencing AMI symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnterior Wall Acute Myocardial Infarction
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 13, 2015
Enrollment StartFeb 1, 2016
Primary CompletionAug 1, 2017
Study CompletionMay 17, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.6 years ago

Interventions

SSO2 Therapydevice

Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter