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Stent

PK Papyrus Covered Coronary Stent System for Coronary Heart Disease

N/A

Recruiting

Led By Luis Bowen, M.D.

Research Sponsored by Methodist Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

Study Summary

This trial is studying a special kind of stent called the PK Papyrus Covered Coronary Stent System. It is being used at Methodist Dallas Medical Center to help patients with a condition called coronary perfor

Who is the study for?

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.Check my eligibility

What is being tested?

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).See study design

What are the potential side effects?

While specific side effects of the PK Papyrus Stent are not listed, common risks associated with stents include bleeding, infection, allergic reactions to materials in the stent, blood clots, and re-narrowing of the artery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determining the number of the unanticipated adverse events related to the use of PK Papyrus Coronary Stent Graft System

Number of patients with the device

Trial Design

1Treatment groups

Experimental Treatment

Group I: PK Papyrus Covered Coronary Stent SystemExperimental Treatment1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Methodist Health SystemLead Sponsor

152 Previous Clinical Trials

4,825,592 Total Patients Enrolled

Luis Bowen, M.D.Principal InvestigatorMethodist Dallas Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for the number of participants that can be enrolled in this medical study?

"Affirmative. The information provided on clinicaltrials.gov suggests that this trial is currently seeking individuals to participate. It was initially posted on August 10th, 2023 and most recently updated on January 16th, 2024. This clinical trial aims to enroll a total of 41 patients from one designated site."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"Indeed, the data available on clinicaltrials.gov indicates that this particular study is actively seeking individuals to participate. The trial was initially posted on August 10th, 2023 and underwent its most recent update on January 16th, 2024. In total, the study aims to recruit a pool of 41 participants from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PK Papyrus Covered Coronary Stent System

2023. "PK Papyrus Covered Coronary Stent System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06223633.

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