Coronary Artery DiseaseSUPPORT IINCT07296744
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
A study testing The Supira System and Impella in people with Coronary Artery Disease and High Risk Percutaneous Coronary Intervention, run by Supira Medical at 25 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease, High Risk Percutaneous Coronary Intervention, Interventional Cardiology
- What is being tested?
- The Supira System and Impella
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 25 sitesUnited States
- Study dates
- 11 May 2026to Nov 2027
- Phase
- Interventional
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
Who may be able to join
- Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary, as determined by the institutional Heart Team
- Informed consent granted by the subject or legally authorized representative
Who cannot join
- Cardiogenic shock or acutely decompensated pre-existing chronic heart failure
- Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
- Left ventricular thrombus
- Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device or the comparator device
- Ongoing renal replacement therapy with dialysis
- Presence of decompensated liver disease; severe liver dysfunction
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- Infection of the proposed procedural access site or active infection
- 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
- Any condition, coagulopathy, planned procedure or contraindication that requires discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure
- Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure
- Currently participating in active follow-up phase of another clinical study of an investigational drug or device or planning to enroll in such a study within 90 days of the HRPCI procedure
- 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
- Considered to be part of a vulnerable population per the investigator's assessment
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chris DeMorett contact
25 sites in 1 country
United States25 sites, 25 recruiting
- Recruiting
Mission Health
Asheville, North Carolina, 28803
Josie Routhier, 828-274-6001, Josephine.Routhier@HCAHealthcare.com
Michael Chenier, M.D.
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309
David Kandzari, M.D.
David Kandzari, M.D.
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Bill Nicholson, M.D., wei.xu@emory.edu
Bill Nicholson, M.D.
- Recruiting
University of Buffalo (Buffalo General)
Buffalo, New York, 14203
Vijay Iyer, M.D., 716-710-8266, ehejna@buffalo.edu
Vijay Iyer, M.D.
- Recruiting
Virtua Health
Camden, New Jersey, 08103
Kristin Wade, 856-355-1225, KMWADE@virtua.org
Kintur Sanghvi, M.D>
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Joaquim Barboza, M.D., 312-664-3278, droshevs@nm.org
Joaquim Barboza, M.D.
- Recruiting
Prisma Health
Columbia, South Carolina, 29203
Vince Vismara, M.D., 803-434-3800, Suzanne.Smith@PrismaHealth.org
Vince Vismara, M.D.
- Recruiting
OhioHealth
Columbus, Ohio, 43214
Arash Arshi, M.D., 614-262-6772, joanna.flores-jones@ohiohealth.com
Arash Arshi, M.D.
- Recruiting
Henry Ford Health / St. John Hospital
Detroit, Michigan, 48236
Amir Kaki, M.D.
Amir Kaki, M.D.
- Recruiting
Northside Hospital
Lawrenceville, Georgia, 30046
Troy Crain, 678-312-3828, Troy.Crain@northside.com
Michele Voeltz, M.D.
- Recruiting
Loma Linda University Medical Center
Loma Linda, California, 92354
Vinoy Prasad, M.D., 909-558-4200, khefflin@llu.edu
VInoy Prasad, M.D.
- Recruiting
University of Miami
Miami, Florida, 33136
Barbara Lang, 305-243-4950, blang@med.miami.edu
Aditya Bharadwaj, M.D.
- Recruiting
Intermountain Health
Murray, Utah, 84107
Savanna Chhak, 801-507-4731, Savanna.Chhak@imail.org
Mitul Patel, M.D.
- Recruiting
Cuimc/Nyph
New York, New York, 10032
Megha Prasad, M.D.
Megha Prasad, M.D.
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Joyce Wald, D.O., 215-615-4949, alyson.brown@pennmedicine.upenn.edu
Joyce Wald, D.O.
- Recruiting
Baylor Scott & White The Heart Hospital
Plano, Texas, 75093
Karim Al-Azizi, M.D., 469-800-6300, Osniel.GonzalezRamos@BSWHealth.org
Karim Al-Azizi, M.D.
- Recruiting
Providence
Portland, Oregon, 97225
Sheryl Ames, 503-216-2099, Sheryl.Ames@providence.org
Kathryn Dawson, M.D.
- Recruiting
OHSU
Portland, Oregon, 97239
Firas Zahr, M.D., 503-494-1775, sampsonna@ohsu.edu
Firas Zahr, M.D.
- Recruiting
UC Davis
Sacramento, California, 95817
Garrett Wong, M.D.
Garrett Wong, M.D.
- Recruiting
CentraCare
Saint Cloud, Minnesota, 56362
Stephen Kidd, M.D.
Stephen Kidd, M.D.
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
John Lasala, M.D., 314-362-1291, cjenifer@wustl.edu
John Lasala, M.D.
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Andrea Mignatti, M.D.
Andrea Mignatti, M.D.
- Recruiting
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Saibal Kar, M.D., 805-852-9100, mane.arabyan@hcahealthcare.com
Saibal Kar, M.D.
- Recruiting
Oklahoma Heart Hillcrest Medical
Tulsa, Oklahoma, 74104
Kamran Muhammad, M.D.
Kamran Muhammad, M.D.
- Recruiting
Wellspan York Hospital
York, Pennsylvania, 17403
Rhian Davies, D.O., 717-851-5153, hmckinney@wellspan.org
Rhian Davies, D.O.
About this study
Official title: Pivotal Randomized Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
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).
Read the detailed description
The Supira System is a minimally invasive percutaneous ventricular assist device (pVAD) that is intended to provide temporary hemodynamic support (≤ 4 hours) to patients undergoing HRPCI. The Supira Catheter is inserted percutaneously through the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with the pump outlet remaining in the ascending aorta. The pump portion of the Catheter compresses during insertion in the Introducer Sheath and re-expands during use. It actively unloads the left ventricle by pumping blood from the ventricle into the ascending aorta and systemic circulation.
- Conditions
- Coronary Artery Disease, High Risk Percutaneous Coronary Intervention, Interventional Cardiology, Mechanical Circulatory Support
- Being tested
- The Supira System, Impella
- Keywords
- Percutaneous ventricular assist device, Supira System, Mechanical Circulatory Support, US Pivotal
- 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.
The Supira SystemDevice
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 has determined HRPCI is the appropriate therapeutic option.
ImpellaDevice
The current commercially available Impella CP with SmartAssist Catheter is indicated for providing temporary (≤ 6 hours) ventricular support during elective or urgent high risk percutaneous coronary i
| Study group | Role | What they receive |
|---|---|---|
| Supira System | Experimental | Subjects receiving the Supira System Receives: Device: The Supira System |
| Impella | Active comparator | Subjects receiving the Impella Receives: Device: Impella |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Safety and Efficacy Outcomes
- All-cause death
- Myocardial infarction
- Stroke or transient ischemic attack
- Major bleeding
- Major access site-related vascular complications
- Acute Kidney Injury
- Unplanned repeat revascularization
- Sustained hypotensiona during mechanical circulatory support
- Arrythmia requiring cardioversion during pump use
Measured: 30 days
Secondary outcomes (1)
Secondary Outcome Measures
Individual rates of the following outcomes:
- All-cause death
- MI
- Stroke or TIA
- Major bleeding
- Major access site-related vascular complications
- AKI
- Unplanned repeat vascularization
- Cardiovascular re-hospitalization
- Ventricular arrhythmia requiring cardioversion
- Major cardiac structural complications
- Major Hemolysis
Measured: 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start11 May 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, multicenter, open label, randomized controlled trial (RCT). Subjects undergoing HRPCI will be randomized (1:1)
- Masking
- None (open label)
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Supira Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296744
- Sponsor's protocol ID
- CP-10004
- Acronym
- SUPPORT II
- Status last verified
- Oct 2026
- First submitted
- 18 Dec 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No