ConditionCoronary Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMethodist Health System
About this trial
The PK Papyrus Covered Coronary Stent System is a coronary stent being used at Methodist Dallas Medical Center for patients with coronary perforations.
Eligibility criteria
Qualifiers
Patients with acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter
Disqualifiers
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.
Trial design
Treatments tested in this trial
- PK Papyrus Covered Coronary Stent System
Treatment groups
41 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov