|

PK(Pharmacokinetic) Papyrus Covered Coronary Stent System

RECRUITINGN/ASponsored by Methodist Health System
Actively Recruiting
PhaseN/A
SponsorMethodist Health System
Started2023-08-10
Est. completion2027-08
Eligibility
Healthy vol.Accepted
Locations1 site

Summary

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

Eligibility

Healthy volunteers 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.

Conditions2

Coronary DiseaseHeart Disease

Locations1 site

Methodist Dallas Medical Center
Dallas, Texas, 75201

Find trials near these locations

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.