PK(Pharmacokinetic) Papyrus Covered Coronary Stent System

NCT06223633 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-06-10

No results posted yet for this study

Summary

The PK Papyrus Covered Coronary Stent System is a coronary stent being used at Methodist Dallas Medical Center for patients with coronary perforations.

Conditions

  • Coronary Disease

Interventions

DEVICE

PK Papyrus Covered Coronary Stent System

PK Papyrus Covered Coronary Stent System has been approved for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts greater than or equal to 2.75mm in diameter.

Sponsors & Collaborators

  • Methodist Health System

    lead OTHER

Principal Investigators

  • Luis Bowen, M.D. · The Methodist Hospital Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-10
Primary Completion
2027-08-31
Completion
2028-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06223633 on ClinicalTrials.gov