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Cardiogenic shock for Percutaneous Vascular Closure
Study Summary
This trial will assess the feasibility of using the PerQseal device to close femoral arterial access sites in patients who have undergone either cardiogenic shock or PPCI procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Does this clinical research program accept new participants?
"Affirmative. Clinicaltrials.gov indicates that this study, which was first published on June 29th 2021, is presently recruiting participants. Approximately 20 individuals are being sought from 4 distinct clinical sites."
What do researchers expect to discover as a result of this investigation?
"The main objective, set to be assessed over a 20 minute duration according to Vivasure Medical Limited (the trial's sponsor), is Safety: Major Access Site Complications. Additionally, the study will examine secondary objectives such as Safety: Incidence of Minor Access Site Complications measured using FDA-provided definitions, Efficacy: PerQseal® Treatment Success Rate determined by calculating the portion of subjects meeting technical success without major complications against those where deployment was attempted and finally The PerQseal® Device Technical Success Rate which pertains to devices achieving hemostasis with or without adjunctive manual compression at target access sites relative to all"
What is the geographic scope of this experiment?
"Currently, 4 sites are enrolling patients in this study - located at Ridgewood, Buffalo and Stony Brook. It is best to choose the closest centre so as to limit travelling commitments if you decide to join the trial."
How many individuals are being recruited to participate in this research?
"Affirmative. Details available on clinicaltrials.gov verify that this research is currently seeking individuals to participate in the trial, which was first posted June 29th 2021 and last updated April 11th 2022. The study requires 20 patients from 4 distinct sites for enrollment."
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