PK(Pharmacokinetic) Papyrus Covered Coronary Stent System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PK Papyrus Covered Coronary Stent System.
- Who it may be relevant to
- Registry conditions: Coronary Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The PK Papyrus Covered Coronary Stent System is a coronary stent being used at Methodist Dallas Medical Center for patients with coronary perforations.
Detailed description
The FDA has approved the PK Papyrus Covered Coronary Stent System for use in patients being treated for acute perforations of native coronary arteries and coronary bypass grafts in vessels ranging from 2.5 to 5.0 mm in diameter, under a Humanitarian Device Exemption (HDE #H170004). Methodist Dallas Medical Center will use this device for treating the above-described patient population.
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.
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Methodist Dallas Medical Center — Dallas
Identifiers
NCT: NCT06223633 · 078.CAR.2019.D