Supira System for Coronary Artery Disease

(SUPPORT II Trial)

Not yet recruiting at 6 trial locations

Overseen By Supira Medical

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Supira Medical

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device).

Are You a Good Fit for This Trial?

Inclusion Criteria

Informed consent granted by the subject or legally authorized representative

I am stable and scheduled for a planned or urgent high-risk heart procedure with support.

Exclusion Criteria

I have had a recent severe heart problem or worsening chronic heart failure.

I do not have an active infection or infection at the procedure site.

Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to provide written informed consent and/or to comply with study procedures

What Are the Treatments Tested in This Trial?

Interventions

• The Supira System

How Is the Trial Designed?

Group I: Supira System Experimental Treatment 1 Intervention

Subjects receiving the Supira System

Group II: Impella Active Control 1 Intervention

Subjects receiving the Impella

Who Is Running the Clinical Trial?

Supira Medical

Lead Sponsor

Trials

3

Recruited

270+