PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Kardion Inc
Study ID
NCT06445608
Status
Recruiting
Apply to this trial

Conditions

  • Coronary Artery Disease

Eligibility Criteria

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

Interventions

  • Percutaneous Mechanical Circulatory Support — DEVICE
    Patients are randomized to receive one of two types of percutaneous mechanical circulatory support devices during a high-risk PCI procedure.

Study Details

This purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require hemodynamic support during a high-risk PCI procedure.

Key Dates

Start date
Sep 3, 2024
Status verified
Jun 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: KARDION Cory P4 System
  • Active Comparator: Commercial Control

Primary Outcome Measure

MACCE [ Time Frame: 30 days post-procedure ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Dignity Health - Chandler Regional Medical CenterChandlerArizona85224
Ashish Pershad, MD
[email protected]
480-728-9973
HonorHealth Research and Innovation InstituteScottsdaleArizona85258
Taral Patel, MD
[email protected]
480-323-1046
Arkansas Cardiology, P.A.Little RockArkansas72205
Ernesto Ruiz-Rodriguez, MD
[email protected]
501-227-7596
North Suburban Medical CenterThorntonColorado80229
Ehrin Armstrong, MD
[email protected]
415-312-2480
Hartford HospitalHartfordConnecticut06112
Craig Thompson, MD
[email protected]
802-369-6250
Ascension St. Vincent'sJacksonvilleFlorida32204
Samer Garas, MD
[email protected]
904-308-5763
Emory UniversityAtlantaGeorgia30322
William Nicholson, MD
404-712-7665
Ascension St. VincentIndianapolisIndiana46290
Michael Kourany, MD
[email protected]
317-338-8042
Massachusetts General HospitalBostonMassachusetts02114-
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407
Emmanouil Brilakis, MD
[email protected]
612-863-3895
Deborah Heart and Lung CenterBrowns MillsNew Jersey08015
Muhmammad Raza, MD
[email protected]
604-893-1200
Mount SinaiNew YorkNew York10029
Samin Sharma
[email protected]
212-241-9687
St. Francis HospitalRoslynNew York11576
Allen Jeremias, MD
[email protected]
516-562-6790
The Lindner Research Center at The Christ HospitalCincinnatiOhio45219
Jarrod Frizzell, MD
[email protected]
513-585-1777
Ohio Health Research InstituteColumbusOhio43214
Arash Arshi, MD
[email protected]
614-262-6772
Heart and Vascular Research at WellSpan HealthYorkPennsylvania17403
Stewart Benton, MD
[email protected]
717-851-2441
Ascension Saint ThomasNashvilleTennessee37205
Jimmy Kerrigan, MD
[email protected]
615-269-4545
University of WashingtonSeattleWashington98195
Kathleen Kearney, MD
[email protected]
206-221-9154

Find similar trials in Chandler, AZ

By research site
Dignity Health - Chandler Regional Medical Center· Chandler, AZHonorHealth Research and Innovation Institute· Scottsdale, AZArkansas Cardiology, P.A.· Little Rock, ARNorth Suburban Medical Center· Thornton, COHartford Hospital· Hartford, CTAscension St. Vincent's· Jacksonville, FL

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