PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

NCT06445608 | Recruiting DMC FDA Device

• 1 other identifier: 000001057
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

High-risk PCI

Outcome Measures

Primary Outcomes (2)

• MACCE

  The primary effectiveness endpoint of the clinical investigation is a composite endpoint of major adverse cardiac and cerebrovascular events (MACCE) comprised of all-cause death, myocardial infarction, stroke/TIA, target lesion revascularization, vascular complications, major bleeding, and acute kidney injury.

  30 days post-procedure

• Device-Related Safety

  The primary safety endpoint of the clinical investigation is a composite endpoint of device-related safety events (as adjudicated by the CEC) requiring intervention, including cardiac or vascular complication, limb ischemia, increase in aortic insufficiency, or CPR or ventricular arrhythmia requiring cardioversion.

  30 days post-procedure

Secondary Outcomes (6)

• Technical Success

  Index procedure

• Procedural Success

  Index Procedure

• Serious Device-Related Adverse Events

  Index procedure through 30-day follow-up

• Individual MACCE components

  Index procedure through 30-day follow-up

• Death

  Index procedure through 30-day follow-up

Study Arms (2)

KARDION Cory P4 System

EXPERIMENTAL

Device: Percutaneous Mechanical Circulatory Support

Commercial Control

ACTIVE COMPARATOR

Device: Percutaneous Mechanical Circulatory Support

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.

Commercial Control; KARDION Cory P4 System

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject age ≥ 18 and ≤ 90 years at the time of screening
• The subject has an LV ejection fraction of \< 50% (within 90 days of index procedure) AND is at high-risk due to any of the following:
• Unprotected left main coronary artery stenosis disease
• Last remaining epicardial native coronary artery
• Significant three vessel coronary artery disease
• Significant two vessel coronary artery disease of complex lesions
• Significant single vessel coronary artery disease of complex lesions and non-treated CTO
• Target vessel is a CTO with planned retrograde approach
• Intended calcium modification (by atherectomy, lithotripsy or laser)
• In multiple vessels OR
• In the left main OR
• In a final patent conduit OR
• Where the anatomic SYNTAX score is ≥32
• Local heart team (interventional cardiologist, cardiac surgeon) has determined that the subject is an appropriate candidate for a PCI supported with a Mechanical Circulatory Support (MCS) System
• Confirmed access site vasculature greater than 5.5 mm as measured by CT or femoral duplex ultrasound

You may not qualify if:

• Any prior coronary revascularization or revascularization attempt within 30 days prior to index procedure
• STEMI within 7 days prior to index procedure - defined as new ST elevation at the J point in at least 2 contiguous leads of ≥ 2 mm (0.2 mV) in men or ≥ 1.5 mm (0.15 mV) in women in leads V2-V3 and/or of ≥ 1 mm (0.1 mV) in other contiguous chest leads or the limb leads
• Non-STEMI within 7 days prior to index procedure with an elevated cardiac biomarker (CK-MB or Troponin \>1x ULN) without CK-MB or Troponin value down trending
• Cardiac arrest within 7 days prior to index procedure requiring CPR or defibrillation
• Subjects with sustained ventricular tachycardia or repetitive/ prolonged non-sustained ventricular tachycardia or complex ventricular ectopy
• Current left ventricular thrombus
• Significant right heart failure (right ventricular fractional area change \<35% on echocardiography)
• Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) on echo or pulmonary artery systolic pressure (PASP) on right heart catheterization \> 70mmHg
• Combined cardiorespiratory failure
• Presence of an atrial or ventricular septal defect (including post-infarct VSD)
• Hypertrophic obstructive cardiomyopathy (HOCM), restrictive cardiomyopathy, or constrictive pericarditis
• Cardiogenic shock (Cardiac index \< 1.8 L/min/m2)
• Use of inotropic or pressor therapy within 72 hours of the planned index procedure. NOTE: Use of inotropic or pressor therapy for the sole purpose of blood pressure support associated with anesthesia for the procedure is acceptable.
• Any use of mechanical circulatory support or an extracorporeal membrane oxygenation device within 14 days prior to index procedure
• Severe aortic valve insufficiency or stenosis or aortic valve replacement

Sponsors & Collaborators

• Kardion Inc: lead

Study Sites (18)

Dignity Health - Chandler Regional Medical Center

Chandler, Arizona, 85224, United States

RECRUITING

HonorHealth Research and Innovation Institute

Scottsdale, Arizona, 85258, United States

RECRUITING

Arkansas Cardiology, P.A.

Little Rock, Arkansas, 72205, United States

RECRUITING

North Suburban Medical Center

Thornton, Colorado, 80229, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06112, United States

RECRUITING

Ascension St. Vincent's

Jacksonville, Florida, 32204, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Ascension St. Vincent

Indianapolis, Indiana, 46290, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

WITHDRAWN

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

St. Francis Hospital

Roslyn, New York, 11576, United States

RECRUITING

The Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

RECRUITING

Heart and Vascular Research at WellSpan Health

York, Pennsylvania, 17403, United States

RECRUITING

Ascension Saint Thomas

Nashville, Tennessee, 37205, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Samin Sharma, MD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

• William Nicholson, MD

  Emory University

  STUDY CHAIR

Central Study Contacts

Darin R. Lerew

CONTACT

612-276-2716; darin.lerew@kardion.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: September 3, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)