PK Papyrus Stent for Coronary Heart Disease

Overseen By Zaid Haddadin, M.S.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Methodist Health System

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Allergy to silicon carbide, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate

41 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of coronary stent, the PK Papyrus Covered Coronary Stent System. It is designed to help patients with tears in their coronary arteries or bypass grafts, which can lead to serious heart problems. The stent seals these tears to prevent further complications. Patients who have recently experienced a perforation in a coronary artery or bypass graft, in vessels between 2.5 to 5.0 mm wide, might be suitable for this trial. As an unphased trial, it offers patients access to innovative treatment options that could significantly improve heart health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you cannot take antiplatelet or anticoagulation therapy (medications that prevent blood clots).

What prior data suggests that the PK Papyrus Covered Coronary Stent System is safe for coronary perforations?

Previous studies have shown promising safety results for the PK Papyrus Covered Coronary Stent System. Researchers found successful placement in 97.7% of cases and effective sealing of holes in the heart's blood vessels in 92.1% of cases. These results suggest the treatment is generally well-tolerated.

While any medical procedure carries risks, the PK Papyrus stent is considered a safe option for treating coronary perforations. The results have been acceptable, especially given the challenging situations in which it is used. This stent is already approved for treating certain types of coronary perforations, further supporting its safety for this purpose. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The PK Papyrus Covered Coronary Stent System is unique because it is specifically designed to treat coronary artery perforations, where there is free leakage of contrast dye into the pericardium. Unlike standard stents, which primarily focus on keeping arteries open, the PK Papyrus stent combines a unique covered design that acts as a barrier to stop the leakage. Researchers are excited about this stent because it could provide a more immediate and effective solution for sealing perforations, potentially reducing the risk of complications and improving outcomes for patients with this serious condition.

What evidence suggests that the PK Papyrus Covered Coronary Stent System is effective for coronary perforations?

Research shows that the PK Papyrus Covered Coronary Stent System, which participants in this trial will receive, effectively repairs tears in heart blood vessels. In earlier studies, doctors successfully placed the stent in 97.7% of cases, and it sealed the tears in 92.1% of cases. Patients experienced a low rate of major heart problems after the procedure, with the most common issue being the need for additional treatment in about 8.5% of cases. This evidence suggests that the PK Papyrus stent is a reliable option for treating serious heart vessel problems. ^{1 4 5 6 7}

Who Is on the Research Team?

Luis Bowen, M.D.

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for patients with coronary heart disease who have experienced a coronary perforation. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be excluded based on factors like other medical conditions or treatments that could interfere with the study.

Inclusion Criteria

I have a tear in my heart's artery or bypass graft that is between 2.5 to 5.0 mm wide.

Exclusion Criteria

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)

My cancer cannot be treated with the system due to unreachable lesions.

Allergy to contrast media

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PK Papyrus Covered Coronary Stent System for treatment of coronary perforations

Immediate

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

What Are the Treatments Tested in This Trial?

Interventions

• PK Papyrus Covered Coronary Stent System

Trial Overview The PK Papyrus Covered Coronary Stent System is being tested at Methodist Dallas Medical Center. This stent system is designed specifically for patients who have suffered from a tear in their heart's blood vessels (coronary perforations).

How Is the Trial Designed?

Group I: PK Papyrus Covered Coronary Stent System Experimental Treatment 1 Intervention

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.

PK Papyrus Covered Coronary Stent System is already approved in European Union, United States for the following indications:

Approved in European Union as PK Papyrus Covered Coronary Stent System for:

• Acute perforations of native coronary arteries and coronary bypass grafts

Approved in United States as PK Papyrus Covered Coronary Stent System for:

• Acute coronary artery perforations

Who Is Running the Clinical Trial?

Methodist Health System

Lead Sponsor

Trials

156

Recruited

4,826,000+

Published Research Related to This Trial

The PK Papyrus covered stent is designed for emergency treatment of coronary vessel perforations, showing over 90% success rates in both device delivery and sealing perforations, typically requiring only one stent for resolution.

This stent features an ultrathin strut design and a specialized polyurethane matrix, which enhances its delivery and effectiveness compared to other coronary covered stents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PK Papyrus coronary stent system: the ultrathin struts polyurethane-covered stent. Barbero, U., Cerrato, E., Secco, GG., et al.[2021]

The PK Papyrus covered stent demonstrated a high success rate in sealing coronary artery perforations, achieving complete sealing in 93.6% of the 94 patients treated, indicating its efficacy as a second-generation device.

The safety profile showed low rates of target lesion revascularization (7.7% at 12 months) and stent thrombosis (2 cases), with a 12-month mortality rate of 19.0%, suggesting that the stent is a safe option for managing coronary perforations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sealing of Coronary Perforations With a Second-Generation Covered Stent Graft - Results From the PAST-PERF Registry. Birkemeyer, R., Olivecrona, GK., Hellig, F., et al.[2021]

The PK Papyrus covered coronary stent system was successfully used in 97.7% of cases for treating coronary artery perforation (CAP), with a sealing success rate of 92.1%, indicating its high efficacy in managing this serious condition.

In a retrospective analysis of 1094 cases from 335 hospitals, the use of the PK Papyrus stent was associated with a relatively low rate of acute/subacute stent thrombosis (1.1%) and provided significant insights into the safety and outcomes of treating CAP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Experience of the PK Papyrus Covered Stent in Patients With Coronary Artery Perforations: Results From a Multi-Center Humanitarian Device Exemption Survey. Kandzari, DE., Sarao, RC., Waksman, R.[2022]

The PK Papyrus covered stent (PKP) demonstrated a high procedural success rate of 91% in treating coronary artery perforation (CAP) among 130 patients, indicating its effectiveness in critical situations.

However, long-term outcomes showed significant challenges, with a 26% mortality rate and a 17% target lesion revascularization (TLR) rate primarily due to in-stent restenosis (ISR) and stent thrombosis (ST), highlighting the need for ongoing monitoring and management after PKP implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and outcomes of the PK Papyrus covered stent in France: SOS PK Papyrus Registry. Hernández-Enríquez, M., Belle, L., Madiot, H., et al.[2021]

In a study of 80 patients with coronary artery perforation, the PK Papyrus covered stent was successfully delivered in 95% of cases and effectively sealed the perforation in 91.3% of patients, demonstrating its efficacy in treating this serious condition.

Despite the high success rates of the PK Papyrus stent, in-hospital mortality was still significant at 10%, particularly among patients with severe perforations (Ellis grade III), indicating that while the stent is effective, the severity of the injury remains a critical factor in patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PK Papyrus covered stent: Device description and early experience for the treatment of coronary artery perforations. Kandzari, DE., Birkemeyer, R.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35504818/

Clinical Experience of the PK Papyrus Covered Stent in ... Successful PK Papyrus delivery was reported in 97.7% of cases with successful perforation sealing in 92.1%. Emergency cardiac surgery and in-hospital death ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553838922002093

Clinical Experience of the PK Papyrus Covered Stent in ... Successful PK Papyrus delivery was reported in 97.7% of cases with successful perforation sealing in 92.1%. Emergency cardiac surgery and in-hospital death ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39033331/

Meta-analysis of mid to long-term outcomes of PK Papyrus ... This meta-analysis aims to evaluate major adverse cardiac events (MACE) from discharge through long-term follow-up in patients undergoing percutaneous coronary ...

4. trialx.com trialx.com/clinical-trials/listings/282989/pk-papyrus-covered-coronary-stent-system/

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

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ccd.31157

Meta‐analysis of mid to long‐term outcomes of PK Papyrus ... After a mean follow-up of 16.2 months, the MACE was 14.3%, with Target Lesion Revascularization (TLR) being the most frequent (8.5%), followed ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/H170004C.pdf

PK Papyrus This guide explains the probable benefits and potential risks associated with having a PK Papyrus covered stent implanted along with medication.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/H170004B.pdf

Summary of Safety and Probable Benefit (SSPB) The PK Papyrus Covered Coronary Stent System is indicated for the treatment of acute perforations of native coronary arteries and coronary ...