🏛️ Verified NIH Record • Updated 2026-06-08
PK(Pharmacokinetic) Papyrus Covered Coronary Stent System (NCT06223633)
🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Methodist Health System
🩺 Plain-English Summary (8th-Grade Level)
The PK Papyrus Covered Coronary Stent System is a coronary stent being used at Methodist Dallas Medical Center for patients with coronary perforations.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (8 items).
Location: Methodist Dallas Medical Center — Dallas, Texas
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients in whom antiplatelet agents or anticoagulation therapy is contraindicated.
- Patients with a known allergy or hypersensitivity to amorphous silicon carbide or any other compound of the system (siloxane-based polyurethane, L-605 cobalt chromium alloy including tungsten and nickel).
- Lesions that cannot be reached or treated with the system.
- Lesions with threatened or abrupt closure during attempted pre-dilation prior to stent implantation.
- Risk of treatment-related occlusion of vital coronary artery side branches.
- Uncorrected bleeding disorders.
- Allergy to contrast media.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Methodist Dallas Medical Center — Dallas, Texas
💰 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.