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

Part of paid clinical trials in Sacramento, 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

Start date
May 11, 2026
Status verified
Jun 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 (14)

FacilityCityStateZIPSite coordinators
UC DavisSacramentoCalifornia95817
Garrett Wong, M.D.
Garrett Wong, 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)
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) 747-4535
John Lasala, M.D. (PRINCIPAL_INVESTIGATOR)
University of Buffalo (Buffalo General)BuffaloNew York14203
Vijay Iyer, M.D.
[email protected]
(716) 725-4797
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]
614-788-3861
Arash Arshi, M.D. (PRINCIPAL_INVESTIGATOR)
Oklahoma Heart Hillcrest MedicalTulsaOklahoma74104
Kamran Muhammad, M.D.
Kamran Muhammad, 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) 434-7984
Vince Vismara, M.D. (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White The Heart HospitalPlanoTexas75093
Karim Al-Azizi, M.D.
[email protected]
(248) 982-3744
Karim Al-Azizi, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By research site
UC Davis· Sacramento, CAEmory University Hospital· Atlanta, GAPiedmont Heart Institute· Atlanta, GAHenry Ford Health / St. John Hospital· Detroit, MICentraCare· Saint Cloud, MNWashington University in St. Louis· St Louis, MO

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