Status:
COMPLETED
Safety Evaluation of Intracoronary Infusion of Extracellular Vesicles in Patients Following Coronary Stent Implantation
Lead Sponsor:
Christopher J. McLeod
Collaborating Sponsors:
Rion LLC
Conditions:
Percutaneous Coronary Intervention
Eligibility:
All Genders
21-85 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety of using a biological drug called PEP in people who have had a coronary stent placed. A biological drug is a substance that is made from a living o...
Detailed Description
Patients who undergo Percutaneous Coronary Intervention (PCI) will be treated with a single dose of PEP within 20 minutes after stent placement or post-dilation (whichever is last). Subjects will be s...
Eligibility Criteria
Inclusion
- Undergoing ≥1 elective, urgent, or emergent coronary stent implantation
- Angiographic evidence of TIMI 3 flow through the stented vessel after stent placement
- Angiographic evidence of residual stenosis visually \<30% after stent placement
- Willing and able to provide signed informed consent
- Lives within 90 mile radius of study site
- Willing and able to return to study site for all follow-up visits
Exclusion
- Prior solid organ transplantation at any time
- Pregnant or lactating at screening
- Known presence of chronic systemic inflammatory disorder that requires ongoing therapy with immunosuppressive agents
- Known immune system compromise including but not limited to human immunodeficiency virus (HIV), hepatitis A, hepatitis B (HBV) or hepatitis C (HCV) infection
- Known history of malignancy of any type except non-melanoma skin cancer
- Known serum creatinine \>2 mg/dL or GFR ≤30 mL/min within the last twelve months
- Known AST, ALT, and/or bilirubin (total) elevated twice the upper limit of normal for age \& gender within the last twelve months
- Known Hemoglobin lower than 8.0 g/dL within the last twelve months
- Known current illicit drug use at screening
- Other major surgical procedure or major trauma within the previous 14 days prior to enrollment
- Female of child bearing potential who is unwilling to agree to use acceptable contraception methods for 3 months after receiving the investigational drug
- Pacemaker/ICD implant in place
- Adult lacking decision-making capacity
- Prisoner
- Non-English speaking
- English-speaking but illiterate
- Legally blind
- Known allergy to heparin or heparin-induced thrombocytopenia
- Known history of positive SARS-CoV2 testing within the last 30 days
- DNR/DNI status prior to PCI procedure or planned DNR/DNI status after PCI procedure
- Homeless or no permanent address at the time of enrollment
Key Trial Info
Start Date :
November 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04327635
Start Date
November 2 2021
End Date
October 22 2025
Last Update
November 10 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905