A Post Approval Study to Evaluate the Delivery of Hyperoxemic Super Saturated Oxygen Therapy for 60 Minutes in Anterior AMI Patients Compared to PCI

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A multi-center randomized post-approval evaluation of delivery of intracoronary hyperoxemic supersaturated Oxygen therapy for 60 minutes in anterior AMI patients with successful reperfusion (via PCI) within 6 hours after onset of symptoms compared to standard therapy

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ \-

⁃ Pre-PCI:

• The subject must be ≥18 years of age.

• AMI must be anterior (ST-segment elevation \>1 mm in two or more contiguous leads between V1 and V4 or new left bundle branch block).

• The subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).

• Subject and his/her physician agree to all required follow-up procedures and visits.

• ANGIOGRAPHIC INCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent and has undergone cardiac catheterization and PCI if indicated:

• Based on coronary anatomy, PCI is indicated for revascularization of the culprit lesion(s) with use of a commercially available coronary stent (bare metal or drug-eluting, at operator discretion) in the LAD.

• The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery (other lesions in the LAD target vessel, including diagonal branches, may be treated if clinically indicated).

• Successful angioplasty is completed \<6 hrs from symptom onset, as documented by 30% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow and no major complications such as perforation or shock.

• Expected ability to place the SSO2 delivery catheter in the coronary ostium of the left main coronary system to deliver SSO2 Therapy with stable, coaxial alignment.

• Systemic arterial pO2 greater than or equal to 80 mmHg as measured by arterial blood gas (may be repeated if low after supplemental O2 administration).

Locations
United States
Massachusetts
Baystate Medical Center
RECRUITING
Springfield
Contact Information
Primary
Jeffrey Creech, PhD
jcreech@zoll.com
3233096949
Backup
Shailaja Lakma
slakma@zoll.com
9253367743
Time Frame
Start Date: 2022-08-02
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 434
Treatments
Experimental: PCI with SSO2 therapy
AMI subjects treated with SSO2 Therapy following PCI with stenting
Active_comparator: anterior AMI patients treated with PCI and stenting within 6 hours
Control group receiving PCI with stenting alone
Sponsors
Leads: TherOx

This content was sourced from clinicaltrials.gov

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