Recruiting

PK Papyrus

Sponsor:

Methodist Health System

Code:

NCT06223633

Conditions

Coronary Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

PK Papyrus Covered Coronary Stent System

Study Details

Brief 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

Study ID

NCT06223633

Start date

Aug 10, 2023

Status verified date

May, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter

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.

Study Design

Enrollment

41 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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 ]
  • Number of patients with the device [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Colette Ngo Ndjom, M.S.

214-947-1279clinicalresearch@mhd.com

Zaid Haddadin, M.S.

214-947-1280clinicalresearch@mhd.com

Locations

Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75201

More Information

Sponsor

Methodist Health System

Last update posted

Jun 10, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Methodist Health System on 2026-06-10.