|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P170027 / PAS001 |
| Date Original Protocol Accepted |
11/20/2020
|
| Date Current Protocol Accepted |
12/09/2021
|
| Study Name |
New Enrollment Study
|
| Device Name |
TherOx Downstream System
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
To confirm the safety and effectiveness of SSO2 Therapy.
This is a prospective, open-label, randomized (1:1) study.
Subjects who present with anterior STEMI requiring stent placement in the proximal and/or mid LAD who meet all eligibility criteria and provide informed consent will be treated with PCI with stenting, and if successful and uncomplicated then immediately randomized to post-procedure infusion of SSO2 Therapy for a duration of 60 minutes or standard of care.
|
| Study Population |
Qualifying anterior STEMI patients (1 mm or greater of ST elevation in 2 or more contiguous leads in V1-V4) successfully treated with PCI and stenting within 6 hours from time of symptom onset.
|
| Sample Size |
Up to sixty (60) centers including up to 45 centers in the U.S. and no more than 15 centers outside the U.S.
A total of 434 patients randomized (1:1) to SSO2 Therapy (Treatment group) or Standard of Care (Control group) i.e., 217 SSO2 Therapy: 217 Control. A minimum of 50% of study subjects will be enrolled in the US and the maximum per site enrollment is 40 subjects.
The safety sample size is based on the following assumptions:
1:1 randomization between SSO2 Therapy and control arms,
1-year NACE of 18% in SS02 and control patients,
5% loss to follow-up at 1-year,
1-sided non-inferiority test (Farrington-Manning),
Non-inferiority margin of 9.5%,
5% type I error and 80% power
Based on the assumptions above, a total sample size of 412 subjects (206 per group) will provide 80% power to evaluate primary safety, which is increased to 434 subjects (217 per group to account for 5% loss to follow-up.
The effectiveness assumptions are as follows:
27.1% infarct size at 2-7 days in the standard therapy group.
SSO2 Therapy group effect size = 25% relative reduction in 2-7day infarct size
Standard deviation of 16.1% in both treatment arms
Loss to follow-up or missing measurements = 25%
Type I Error = 5% (two-sided)
A total of 324 subjects (162 per group) are needed to achieve 96.6% power for testing the superiority of the SSO2 arm compared to the control arm using a two- sample t-test.
|
| Key Study Endpoints |
Primary Safety endpoint is the 1-year rate of Net Adverse Clinical Events (NACE).
The composite NACE endpoint includes hierarchical total of death (all-cause), reinfarction, target vessel revascularization (ischemia driven), TIMI major bleeding or minor bleeding, New onset heart failure or re-hospitalization for heart failure and Stent thrombosis (ARC definite or probable).
The safety endpoint events will be adjudicated and classified by an independent Clinical Events Committee (CEC).
Primary effectiveness endpoint is the cardiac MRI endpoint of median infarct size (% of total left ventricle (LV) mass) at 2-7 days.
The major powered secondary endpoint is a hierarchical composite of all-cause mortality within 1 year, rehospitalization for heart failure within 1 year, and infarct size measured by cardiac MRI within 2-7 days after PCI.
Additional Non-Powered Endpoints:
MRI Endpoints-
Microvascular obstruction (2-7 days)
Left ventricular ejection fraction (2-7days, and 6 months)
Left ventricular end diastolic volume and volume index (2-7 days, and 6 months)
Left ventricular end systolic volume and volume index (2-7 days, and 6 months)
Change from 2-7 days to 6 months in MRI endpoints:
Infarct size
Left ventricular ejection fraction
Left ventricular end diastolic volume and volume index
Left ventricular end systolic volume and volume index
30-day, 6-month, and 1-year clinical endpoints
Death
Rehospitalization
Reinfarction
Revascularization
Target Lesion Failure
Stent Thrombosis
|
| Follow-up Visits and Length of Follow-up |
12 months
|
