PK(Pharmacokinetic) Papyrus Covered Coronary Stent System
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
PK Papyrus Covered Coronary Stent System
DevicePK 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.
Treatment groups
41 Participants
are divided into 1 treatment groupGroup A: PK Papyrus Covered Coronary Stent SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Determining the number of the unanticipated adverse events related to the use of PK Papyrus Coronary Stent Graft System
Number of patients with PK Papyrus being treated for acute perforations of native coronary arteries and bypass grafts in vessels.
Time frame
Up to 10 years2
Number of patients with the device
number of patients with success coronary artery and bypass grafts
Time frame
10 yearsSponsors and contacts
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Source ClinicalTrials.gov