Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)

Part of paid clinical trials in Loma Linda, California.

Sponsor
Supira Medical
Study ID
NCT07296744
Status
Recruiting
Apply to this trial

Conditions

  • Coronary Artery Disease
  • High Risk Percutaneous Coronary Intervention
  • Interventional Cardiology
  • Mechanical Circulatory Support

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • The Supira System — DEVICE
    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.
  • Impella — DEVICE
    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 Details

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).

Key Dates

First listed
Dec 22, 2025
Start date
May 11, 2026
Status verified
Jul 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
358 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Supira System
    Subjects receiving the Supira System
  • Active Comparator: Impella
    Subjects receiving the Impella

Primary Outcome Measure

Composite Safety and Efficacy Outcomes [ Time Frame: 30 days ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Loma Linda University Medical CenterLoma LindaCalifornia92354
Vinoy Prasad, M.D.
[email protected]
(909) 558-4200
VInoy Prasad, M.D. (PRINCIPAL_INVESTIGATOR)
UC DavisSacramentoCalifornia95817
Garrett Wong, M.D.
Garrett Wong, M.D. (PRINCIPAL_INVESTIGATOR)
Los Robles Regional Medical CenterThousand OaksCalifornia91360
Saibal Kar, M.D.
[email protected]
(805) 852-9100
Saibal Kar, M.D. (PRINCIPAL_INVESTIGATOR)
Emory University HospitalAtlantaGeorgia30322
Bill Nicholson, M.D.
[email protected]
Bill Nicholson, M.D. (PRINCIPAL_INVESTIGATOR)
Piedmont Heart InstituteAtlantaGeorgia30309
David Kandzari, M.D.
David Kandzari, M.D. (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Joaquim Barboza, M.D.
[email protected]
312-664-3278
Joaquim Barboza, M.D. (PRINCIPAL_INVESTIGATOR)
Henry Ford Health / St. John HospitalDetroitMichigan48236
Amir Kaki, M.D.
Amir Kaki, M.D. (PRINCIPAL_INVESTIGATOR)
CentraCareSaint CloudMinnesota56362
Stephen Kidd, M.D.
Stephen Kidd, M.D. (PRINCIPAL_INVESTIGATOR)
Washington University in St. LouisSt LouisMissouri63110
John Lasala, M.D.
[email protected]
314-362-1291
John Lasala, M.D. (PRINCIPAL_INVESTIGATOR)
University of Buffalo (Buffalo General)BuffaloNew York14203
Vijay Iyer, M.D.
[email protected]
716-710-8266
Vijay Iyer, M.D. (PRINCIPAL_INVESTIGATOR)
Cuimc/NyphNew YorkNew York10032
Megha Prasad, M.D.
Megha Prasad, M.D. (PRINCIPAL_INVESTIGATOR)
Ajay Kirtane, M.D. (SUB_INVESTIGATOR)
Montefiore Medical CenterThe BronxNew York10467
Andrea Mignatti, M.D.
Andrea Mignatti, M.D. (PRINCIPAL_INVESTIGATOR)
OhioHealthColumbusOhio43214
Arash Arshi, M.D.
[email protected]
614-262-6772
Arash Arshi, M.D. (PRINCIPAL_INVESTIGATOR)
Oklahoma Heart Hillcrest MedicalTulsaOklahoma74104
Kamran Muhammad, M.D.
Kamran Muhammad, M.D. (PRINCIPAL_INVESTIGATOR)
OHSUPortlandOregon97239
Firas Zahr, M.D.
[email protected]
503-494-1775
Firas Zahr, M.D. (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Joyce Wald, D.O.
[email protected]
215-615-4949
Joyce Wald, D.O. (PRINCIPAL_INVESTIGATOR)
Jay Giri, M.D. (PRINCIPAL_INVESTIGATOR)
Wellspan York HospitalYorkPennsylvania17403
Rhian Davies, D.O.
[email protected]
(717) 851-5153
Rhian Davies, D.O. (PRINCIPAL_INVESTIGATOR)
Prisma HealthColumbiaSouth Carolina29203
Vince Vismara, M.D.
[email protected]
803-434-3800
Vince Vismara, M.D. (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White The Heart HospitalPlanoTexas75093
Karim Al-Azizi, M.D.
[email protected]
469-800-6300
Karim Al-Azizi, M.D. (PRINCIPAL_INVESTIGATOR)

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