PK(Pharmacokinetic) Papyrus Covered Coronary Stent System

Part of paid clinical trials in Dallas, Texas.

Sponsor
Methodist Health System
Study ID
NCT06223633
Status
Recruiting
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Conditions

  • Coronary Disease

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • PK Papyrus Covered Coronary Stent System — DEVICE
    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.

Study Details

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

Key Dates

Start date
Aug 10, 2023
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
41 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Determining the number of the unanticipated adverse events related to the use of PK Papyrus Coronary Stent Graft System [ Time Frame: Up to 10 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Methodist Dallas Medical CenterDallasTexas75201-

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By research site
Methodist Dallas Medical Center· Dallas, TX

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