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

Trial Summary

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 data supports the effectiveness of the PK Papyrus Covered Coronary Stent System treatment for coronary heart disease?

The PK Papyrus stent is shown to be effective in sealing coronary artery perforations, with studies reporting over 90% success in device delivery and perforation sealing. This suggests it could be a reliable option for treating similar issues in coronary heart disease. ^{1 2 3 4 5}

Is the PK Papyrus Stent safe for use in humans?

The PK Papyrus Stent has been used to treat coronary artery perforations, and studies show it successfully seals these perforations in over 90% of cases, usually with just one stent. It is approved for use in the U.S. under a special exemption, indicating it meets certain safety standards for this specific use. ^{1 2 3 4 5}

How is the PK Papyrus Stent treatment different from other treatments for coronary heart disease?

The PK Papyrus Stent is unique because it is specifically designed to seal perforations (holes) in coronary arteries, using an ultrathin structure covered with a special material called polyurethane. This makes it particularly effective in emergency situations where a quick and reliable solution is needed to prevent complications like bleeding. ^{1 2 3 4 5}

What is the purpose of 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.

Research Team

Luis Bowen, M.D.

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Use and outcomes of the PK Papyrus covered stent in France: SOS PK Papyrus Registry. [2021]

3. England pubmed.ncbi.nlm.nih.gov

PK Papyrus coronary stent system: the ultrathin struts polyurethane-covered stent. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Sealing of Coronary Perforations With a Second-Generation Covered Stent Graft - Results From the PAST-PERF Registry. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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