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Coronary Artery DiseaseNCT06087575

Early Feasibility Study of the Supira System in Patients Undergoing HRPCI

A study testing Supira System in people with Coronary Artery Disease and High-risk Percutaneous Coronary Intervention, run by Supira Medical at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. The clinical data may be used to support subsequent regulatory applications and further evaluation of the Supira System. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Supira System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
4 sitesUnited States
Study dates
4 Oct 2024to 17 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Subjects will be eligible for inclusion in this study if all of the following criteria apply:

  1. Age ≥18 and ≤90 years
  2. Subject is hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is needed, as determined by the institutional heart team
  3. Informed consent granted by the patient or legally authorized representative

Subjects who meet any one of the following criteria will be excluded from study participation:

  1. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure
  2. Note: Cardiogenic shock is defined as: systemic hypotension (systolic blood pressure (BP) <90 mmHg or the need for inotropes/pressors to maintain a systolic BP >90 mmHg) plus one of the following: any requirement for inotropes/pressors prior to arrival at the catheterization laboratory, clinical evidence of end-organ hypoperfusion or use of intra-aortic balloon pump (IABP), or any other circulatory support device.
  3. Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
  4. Evidence of left ventricular thrombus as assessed by Transthoracic Echocardiogram (TTE)
  5. Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE)
  6. Aortic stenosis categorized as moderate or greater (gradient >20 mmHg or valve area <1.5 cm^2 as assessed on TTE)
  7. Previous aortic valve replacement or reconstruction
  8. Ascending or descending aortic dissection or aortic aneurysm >4.5 cm
  9. Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device
  10. Presence of decompensated liver disease; severe liver dysfunction (Child class C)
  11. Ongoing renal replacement therapy with dialysis
  12. Infection of the proposed procedural access site or systemic active infection requiring ongoing antibiotic therapy
  13. Heparin-induced thrombocytopenia, current or any prior occurrences
  14. Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or known hypersensitivity to heparin, aspirin, adenosine diphosphate (ADP) receptor inhibitors, or nitinol
  15. Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000/mm³ or spontaneous International Normalized Ratio (INR) ≥1.5 or known fibrinogen ≤1.5 g/L)
  16. Any condition or scheduled surgery that will require discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure
  17. Planned coronary intervention within 30 days post index procedure
  18. Breastfeeding or pregnant
  19. Currently participating in active follow-up phase of another clinical study of an investigational drug or device
  20. Active COVID-related infection or prior COVID-19 diagnosis with sequelae that could confound endpoint assessments
  21. 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
  22. Considered to be part of a vulnerable population (defined as individuals with mental disability, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Piedmont Heart Institute Cardiovascular Research

    Atlanta, Georgia, 30309

  • Mount Sinai

    New York, New York, 10029

  • University of California Davis (UC Davis) Medical Center

    Sacramento, California, 95817

  • Montefiore Medical Center Cardiology Research

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Early Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) - The SUPPORT I Trial

The objective of this study is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. The clinical data may be used to support subsequent regulatory applications and further evaluation of the Supira System.

Read the detailed description

The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent HRPCI performed in hemodynamically stable patients with severe coronary artery disease when a heart team, including a cardiac surgeon, has determined HRPCI is the appropriate therapeutic option.

Being tested
Supira System
Keywords
left ventricular assist device (LVAD), peripheral mechanical circulatory support (MCS), Supira System
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supira SystemDevice

    The Supira System is a minimally invasive, miniaturized percutaneous ventricular assist device (pVAD) system that is intended to provide temporary (≤4 hours) hemodynamic support to patients undergoing a HRPCI procedure. The Catheter is inserted percutaneously via the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with a portion remaining in the ascending aorta. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.

Study groups in NCT06087575
Study groupRoleWhat they receive
Supira SystemExperimentalVentricular support indicated for use during elective or urgent high-risk percutaneous coronary interventions.
Receives: Device: Supira System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility: Successful initiation and maintenance of hemodynamic support

    Successful initiation and maintenance of hemodynamic support without severe hypotension throughout the index procedure. Sustained hypotension is defined as sustained mean arterial pressure (MAP) < 60 mmHg requiring inotropic/pressor medications or alternative mechanical circulatory support.

    Measured: From device delivery through removal (up to 4 hours)

  2. Safety: Rate of composite major device-related adverse events (MDRAEs), from device insertion through device removal (inclusive of Supira procedure-related SAEs).

    MDRAEs are defined as any serious adverse events that are adjudicated by the Clinical Events Committee (CEC) as definitely or probably related to the Supira System.

    Measured: From device delivery through device removal (up to 4 hours)

Secondary outcomes (5)

  1. Technical Success

    Rate of technical success, defined as completion of the entire Supira System procedure, including delivery, operation without device malfunction, and successful removal of the Catheter

    Measured: From device delivery through device removal (up to 4 hours)

  2. Procedural Success

    Rate of procedural success, defined as the rate of technical success without procedural SAEs.

    Measured: From device delivery through device removal (up to 4 hours)

  3. Rate of composite MDRAEs from device removal through hospital discharge or 72 hours post-procedure, whichever occurs first.

    Measured: From device removal through hospital discharge or 72 hours post-procedure (whichever occurs first) through 30 days post device removal.

  4. Rate of composite MDRAEs from hospital discharge or 72 hours post-procedure (whichever occurs first) through 30 days post device removal.

    Measured: From hospital discharge or 72 hours post-procedure (whichever occurs first) through 30 days post device removal.

  5. Rate of composite MDRAEs from 30 days to 90 days post device removal.

    Measured: From 30 days to 90 days post device removal.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2023
  2. Study start4 Oct 2024
  3. Primary completion25 Feb 2025
  4. Study completion17 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
The study is a prospective, non-randomized, single-arm, multicenter, feasibility study
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06087575
Sponsor's protocol ID
CP-10003
Status last verified
Feb 2026
First submitted
5 Oct 2023
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Kandzari DE, Mignatti A, Kini A, Wong G, Singh G, Latib A, Costa R, Campos CM, Abizaid A. Clinical Experience With a Novel Percutaneous LV Assist Device in High-Risk PCI: Primary Results From the SUPPORT I Study. Circ Cardiovasc Interv. 2026 May 5:e016010. doi: 10.1161/CIRCINTERVENTIONS.125.016010. Online ahead of print.

    PubMed 42083862

Questions about this trial

What is this clinical trial studying?

A study testing Supira System in people with Coronary Artery Disease and High-risk Percutaneous Coronary Intervention, run by Supira Medical at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Successful initiation and maintenance of hemodynamic support (time frame: From device delivery through removal (up to 4 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06087575, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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