PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm (NCT06445608)
PICANTE: PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Dignity Health - Chandler Regional Medical Center — Chandler, Arizona
Age range: 18 Years to 90 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (18 Sites)
- Dignity Health - Chandler Regional Medical Center — Chandler, Arizona
- HonorHealth Research and Innovation Institute — Scottsdale, Arizona
- Arkansas Cardiology, P.A. — Little Rock, Arkansas
- North Suburban Medical Center — Thornton, Colorado
- Hartford Hospital — Hartford, Connecticut
- Ascension St. Vincent's — Jacksonville, Florida
- Emory University — Atlanta, Georgia
- Ascension St. Vincent — Indianapolis, Indiana
- Massachusetts General Hospital — Boston, Massachusetts
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota
- Deborah Heart and Lung Center — Browns Mills, New Jersey
- Mount Sinai — New York, New York
- St. Francis Hospital — Roslyn, New York
- The Lindner Research Center at The Christ Hospital — Cincinnati, Ohio
- Ohio Health Research Institute — Columbus, Ohio
- Heart and Vascular Research at WellSpan Health — York, Pennsylvania
- Ascension Saint Thomas — Nashville, Tennessee
- University of Washington — Seattle, Washington
📞 Contact the Study Coordinator
Phone: (612) 276-2716
Email: darin.lerew@kardion.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.