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VIOLA Post Market Surveillance Clinical Protocol

Vascular Graft Solutions Ltd. · 2023
ClinicalTrials.gov · Datasets · License: Public Domain · 2023
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coronary-artery-diseasena
The goal of this post marketing surveillance clinical trial is to learn about VIOLA as a proximal seal device in patients undergoing coronary artery grafting (CABG) surgery. The main objective is to evaluate the clinical safety and performance of the VIOLA. Participants will be treated with routine CABG with use of VIOLA for maintaining hemostasis when suturing the proximal anastomosis. Patients will be followed for any clinical events at 6 weeks and 9 months post surgery.
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