Using a special stent to treat coronary artery perforations
Official title: PK(Pharmacokinetic) Papyrus Covered Coronary Stent System
Run by Methodist Health System · NCT06223633 · Data updated 2026-11-12
This study tests a special stent to see if it can help patients with sudden tears in their coronary arteries feel better and avoid serious problems.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 41 (estimated) |
| Sponsor | Methodist Health System Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | August 10, 2023 |
| Main results expected | August 2027 |
| Study ends | August 2028 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT06223633 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with acute perforations of native coronary arteries or coronary bypass grafts within the specified diameter range.
✕Probably not a fit
Patients who cannot tolerate antiplatelet or anticoagulation therapy, or those with specific allergies or conditions that contraindicate the use of the stent, may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The PK Papyrus Covered Coronary Stent System is designed for patients experiencing acute perforations in their coronary arteries or bypass grafts. This interventional approach is being implemented at Methodist Dallas Medical Center, where the stent is used to provide support and prevent further complications in affected vessels ranging from 2.5 to 5.0 mm in diameter. The device has received FDA approval under a Humanitarian Device Exemption, allowing its use in this specific patient population.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce complications and improve outcomes for patients with coronary artery perforations.
How similar studies have gone: While this approach is based on existing technology, the specific application of the PK Papyrus stent for this condition is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Methodist Dallas Medical Center
Dallas, Texas, United States Recruiting
Study contacts
- Principal investigator: Luis Bowen, M.D. — The Methodist Hospital Research Institute
- Study coordinator: Colette Ngo Ndjom, M.S.
- Email: clinicalresearch@mhd.com
- Phone: 214-947-1279
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.